S 1400 Session 111 (1995-1996)
S 1400 General Bill, By Giese
A Bill to amend Chapter 43, Title 40, as amended, Code of Laws of South
Carolina, 1976, relating to pharmacists, so as to revise the manner in which
pharmacists are licensed, regulated, and supervised, and the manner in which
pharmacists conduct their business.
04/29/96 Senate Introduced and read first time SJ-9
04/29/96 Senate Referred to Committee on Medical Affairs SJ-9
A BILL
TO AMEND CHAPTER 43, TITLE 40, AS AMENDED, CODE
OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO
PHARMACISTS, SO AS TO REVISE THE MANNER IN WHICH
PHARMACISTS ARE LICENSED, REGULATED, AND
SUPERVISED, AND THE MANNER IN WHICH
PHARMACISTS CONDUCT THEIR BUSINESS.
Be it enacted by the General Assembly of the State of South
Carolina:
SECTION 1. Chapter 43, Title 40, as amended, of the 1976
Code is further amended to read:
"CHAPTER 43
Pharmacists
SECTION 40-43-10. (A) There is created the State Board of
Pharmacy to be composed of eight members, appointed by the
Governor with advice and consent of the Senate, one of whom must
be a lay member from the State at large, one of whom must be a
pharmacist from the State at large, and six of whom must be
pharmacists representing each of the six congressional districts.
(B) The pharmacist at large and the lay member shall serve
coterminously with the appointing Governor and until their
successors are appointed and qualify. The board shall conduct an
election to nominate three pharmacists from each congressional
district to be submitted to the Governor for consideration for
appointment. The Governor shall appoint one pharmacist to
represent each congressional district from among the nominees
submitted for that district. The election shall provide for
participation by all pharmacists currently licensed and residing in
the congressional district for which the nomination is being made.
The pharmacists elected must be residents of the congressional
district they represent, licensed and in good standing to practice
pharmacy in this State, and actively engaged in the practice of
pharmacy in this State. The members of the board representing the
six congressional districts shall serve for terms of six years and
until their successors are appointed and qualify. No member may
serve more than two successive terms of office except that a
member serving an unexpired term may be reelected and
reappointed for two successive terms.
(C) Before January sixteenth in the year in which the term
expires for a member representing a congressional district, a
qualified pharmacist desiring to be a candidate for the board must
submit to the secretary of the board a biography, a photograph, and
a petition bearing the signatures of a minimum of fifteen
pharmacists practicing in that pharmacist's congressional district.
The secretary shall prepare ballots for mailing to all pharmacists
licensed and residing in the congressional district for which the
nomination is being made. The ballots must be in a form so as to
make tabulation quick and easy and shall contain the names of the
nominees in alphabetical order. Enclosures to accompany the ballots
shall include the envelope in which the ballot is to be sealed and an
envelope addressed to the secretary of the board. The addressed
envelope shall contain a statement headed "information
required" on which must be typed or printed the name of the
voter and a space for the voter's signature certifying that the voter:
(1) is the person whose name appears on the statement;
(2) is eligible to vote in this election;
(3) has personally cast the ballot.
(D) All ballots must be mailed by the secretary before April
second to the last known mailing address of all pharmacists residing
in the congressional district for which the nomination is being made
and must be returned to the secretary postmarked before May
second and received by the office before May eleventh. The
secretary of the board shall certify these ballots to be true and valid.
(E) Before June second, the board shall certify in writing to the
Governor the names of the three persons winning the election and
the name of the person on the board the nominees are being
considered to replace. The member, when appointed by the
Governor, takes office the first of July of that year.
(F) Notwithstanding subsection (B), if a nominee is judged unfit
by the Governor, the board must be informed and other nominees
must be submitted in like manner.
(G) Vacancies must be filled in the manner of the original
appointment for the unexpired portion of the term.
(H) The Governor may remove a member of the board who is
guilty of continued neglect of board duties or who is found to be
incompetent, unprofessional, or dishonorable. No member may be
removed without first giving the member an opportunity to refute
the charges filed against that member.
SECTION 40-43-20. The board is styled "The Board of
Pharmacy" (board) and shall meet in the City of Columbia or
any other place in the State designated by the board at least three
times a year. The board may meet additionally for administrative
purposes at the call of the chairman or of two-thirds of its
members.
A simple majority of the members of the board constitutes a
quorum for the transaction of business. The board may elect a
chairman and a vice-chairman and may also adopt regulations
needed for the proper administration and enforcement of this
chapter. The regulations may not conflict with any of the provisions
of this chapter and shall comply with the provisions of Act 176 of
1977 (Administrative Procedures Act).
SECTION 40-43-30. Every pharmacist who engages in the
practice of pharmacy in this State shall have a license from the
Board of Pharmacy.
SECTION 40-43-40. The Board of Pharmacy alone possesses
and shall exercise all the powers with respect to the licenses of
pharmacists and permits for drug outlets.
SECTION 40-43-50. An applicant for examination as a licensed
pharmacist must be a graduate from a school, college, or
department of pharmacy of a university which is recognized by the
board, the recognition to be established by the board on the basis of
uniform and reasonable standards of educational requirements to be
observed by schools, colleges, or departments of pharmacy of
universities.
Applicants shall furnish proof of attendance at the school,
college, or department of pharmacy from which the applicant is a
graduate. All applicants for licensure by examination also shall
obtain a total of one thousand, five hundred hours of practical
experience in the practice of pharmacy under terms and conditions
as the board determines. The board shall establish standards for
internship or any other program necessary to qualify an applicant
for the licensure examination and also shall determine the necessary
qualifications of any supervising pharmacist or preceptor used in
any internship or other program. The board may issue pharmacy
intern certificates to qualified candidates and set a fee for the
certificate by regulation.
Any applicant who is a graduate from a school, college, or
department of pharmacy of a university located outside the United
States which has not been recognized by the board and who is
otherwise qualified to apply for a license to practice pharmacy in
this State may be considered to have satisfied the graduation
requirements of this section by verification to the board of his
academic record and his graduation and by meeting any other
requirements the board may establish. The board may require the
applicant described in this paragraph to pass successfully an
examination or examinations given or approved by the board to
establish proficiency in English and equivalency of education of this
applicant with qualified graduates from a school, college, or
department of pharmacy of a university recognized by the board as
a prerequisite to taking the examination for licensure.
Any physician, licensed to practice medicine in this State, must
also be allowed to take the examination for the practice of
pharmacy, as provided herein.
SECTION 40-43-60. After June 30, 1956, the Board of
Pharmacy may not examine or license any person within this State
as an assistant pharmacist. Nothing in this section may be construed
as preventing any person holding a license as an assistant
pharmacist on July 1, 1956, from continuing to practice within this
State.
SECTION 40-43-70. The fee for examining an applicant to be a
licensed pharmacist must be set by regulation in an amount
sufficient to cover the cost and administration of the examination.
SECTION 40-43-80. The Board of Pharmacy may not issue a
temporary license.
SECTION 40-43-90. The Board of Pharmacy may issue a
license as a pharmacist to any person who furnishes with his
application satisfactory proof that he has been licensed by
examination in some other state requiring at the time of the
licensure a degree of competency equal to that required of an
applicant in this State at that time. The fee for reciprocity must be
set by the board by regulation.
SECTION 40-43-100. It is unlawful for the permit holder of
any drug outlet to allow any person not qualified in accordance
with the provisions of this chapter to dispense prescriptions of
licensed practitioners authorized to prescribe, except under the
personal supervision of a licensed pharmacist. Nothing in this
chapter may be construed as intending to hinder or prohibit any
physician, dentist, podiatrist, or veterinarian lawfully engaged in the
practice of his profession anywhere within this State from
dispensing his own medicines.
Physicians who are in charge or who directly supervise the
operation of emergency rooms shall dispense legend drugs in order
to meet the immediate needs of the patient. The amount dispensed
shall not exceed an amount equal to a seventy-two hour supply.
Records of drugs dispensed shall be maintained.
SECTION 40-43-110. No licensed pharmacist may have
personal supervision of more than one pharmacy at the same time.
SECTION 40-43-120. An assistant pharmacist may take charge
of a pharmacy during the temporary absence of the licensed
pharmacist but may not own, conduct, or operate a pharmacy unless
he employs a licensed pharmacist and places him in active charge
of all professional duties connected with the proper and lawful
conduct of the business. The board shall promulgate regulations
clearly defining temporary absence.
SECTION 40-43-130. [Section repealed]
SECTION 40-43-135. The responsibility for the enforcement
of the provisions of this chapter is vested in the Board of
Pharmacy. The board has all of the duties, powers, and authority
granted by and necessary to the enforcement of this chapter. The
board shall regulate the practice of pharmacy. Its duties include,
but are not limited to, determining the ethical and professional
competence, on a continuing basis through continuing education, of
pharmacists and for disciplining them and the compounding,
dispensing, and sale of drugs and the required recordkeeping for the
sale of drugs. However, the board's inspection authority over the
inpatient pharmacy of a hospital applies only to recordkeeping
activities of drugs dispensed by the pharmacy. Further, the
responsibility for inspections of the hospital inpatient pharmacy is
delegated to the Department of Health and Environmental Control
as part of its licensing process. These inspections must be conducted
by a licensed pharmacist.
The board shall regulate the operation of drug outlets including,
but not limited to, the compounding, manufacturing, sale, and
distribution of drugs bearing the legend `Caution - federal law
prohibits dispensing without a prescription'. In so doing, the board
shall make, publish, supervise, and enforce regulations for the
operation of drug outlets, including the operation of pharmacies, the
inspection of weights and measures used in the prescription
departments of pharmacies, the compounding, dispensing and sale
of drugs, medicines, poisons, and prescriptions, and the necessary
recordkeeping. It shall prescribe minimum standards for technical
equipment, sanitation, reference materials, and the currently dated
inventory of drugs in all drug outlets.
When the board has reason to believe that any person is violating
or intends to violate any provisions of this chapter it may, in
addition to all other remedies, order the person to immediately
refrain from the conduct. The board may apply to an administrative
law judge as provided under Article 5 of Chapter 23 of Title 1 for
an injunction restraining the person from the conduct. An
administrative law judge as provided under Article 5 of Chapter 23
of Title 1 may issue a temporary injunction ex parte and upon
notice and full hearing may issue any other order in the matter it
considers proper. No bond is required from the board by an
administrative law judge as a condition to the issuance of any
injunction or other action contemplated by the provisions of this
section.
Nothing in this section authorizes the board to make regulations
concerning the prices of goods or drugs sold by outlets, the hours
that the businesses may be operated, or the hours of work of the
employees of the businesses.
SECTION 40-43-140. (A) It is unlawful for a person, except a
pharmacist licensed under this chapter and pursuant to the
regulations of the Board of Pharmacy to:
(1) take, use, or exhibit the title "Pharmacist",
"Druggist", "Pharmacy",
"Drugstore", "Drugs",
"Prescriptions", or any other title, sign, display, or
declaration that tends to lead the public to believe that the person is
engaged in the business of selling, compounding, or dispensing any
medicinal drugs, medicinal chemicals, pharmaceutical preparations,
or biologicals; or
(2) have charge of, engage in, or carry on, for himself or
another, the dispensing, compounding, or sale of any medicinal
drugs, medicinal chemicals, pharmaceutical preparations, or
biologicals within this State.
(B) Except as prescribed by the provisions of this chapter, it is
unlawful for a person to practice as a licensed pharmacist or to
advertise or represent himself by a title, sign, display, declaration,
or other item to be a licensed pharmacist or to engage in, conduct,
carry on, or be employed in the dispensing, compounding, or
retailing of any medicinal drugs, medicinal chemicals,
pharmaceutical preparations, or biologicals within this State.
(C) This section must not be construed as precluding a person
from owning or being a permit holder for a pharmacy, if all of the
dispensing, compounding, and retailing of medicinal drugs,
medicinal chemicals, pharmaceutical preparations, and biologicals in
it are under the supervision and direction of a licensed pharmacist.
(D) A person who violates the provisions of this section is guilty
of a misdemeanor and, upon conviction, must be punished as
provided in Section 40-43-320.
SECTION 40-43-150. (A) Except as provided by Chapters 37
and 38 of Title 40, it is unlawful for a person to sell, give away,
barter, exchange, distribute, or possess in the State, except on a
prescription of a licensed medical or osteopathic physician,
podiatrist, dentist, nurse practitioner, or veterinarian a drug or
device, other than contact lenses, as defined in Section 39-23-20
bearing on its manufacturer's or distributor's original commercial
container the legend, "CAUTION: Federal law prohibits
dispensing without a prescription" and those which, in the
discretion of the Board of Pharmacy, are classified as
"dangerous drugs" within the meaning of this section.
(B) The prescription must be compounded or prepared only by a
licensed pharmacist, licensed assistant pharmacist, or under the
direct personal supervision of a licensed pharmacist. No
prescription may be refilled except upon the authorization of a
licensed medical or osteopathic physician, podiatrist, dentist, nurse
practitioner, or veterinarian who prescribed it, except that if a
pharmacist receives a request for a prescription refill and the
pharmacist is unable to obtain refill authorization from the
prescriber, the pharmacist may dispense a one-time emergency refill
of up to a seventy-two hour supply of the prescribed medication if:
(1) the prescription is not for a controlled substance;
(2) the medication is essential to the maintenance of life or to
the continuation of therapy;
(3) in the pharmacist's professional judgment, the interruption
of therapy reasonably may produce undesirable health
consequences or may cause physical or mental discomfort;
(4) the pharmacist properly records the dispensing; and
(5) the dispensing pharmacist notifies the prescriber of the
emergency dispensing within seventy-two hours after the one-time
emergency refill dispensing.
No prescription marked "PRN" or for another
nonspecific number of refills may be refilled more than two years
beyond the date it was written originally. Nothing in this
subsection abridges the right of a pharmacist to refuse to fill or
refill a prescription.
(C) This section does not apply to the sale at wholesale by
recognized drug jobbers or wholesalers or drug manufacturers to
pharmacists or drug outlets or licensed medical or osteopathic
physicians, podiatrists, dentists, or veterinarians qualified to practice
their professions according to the laws of this State, nor to the sale
by pharmacists in drug outlets to one another. This section applies
to the sale by a manufacturer, wholesaler, or retailer to a person
other than those legally qualified and authorized to purchase and
hold them for resale in this State.
SECTION 40-43-155.(A) Licensed pharmacists may sell
pharmaceutical agents, other than controlled substances as defined
in Section 44-53-110, to optometrists who are diagnostically
certified by the South Carolina Board of Examiners in Optometry
for diagnostic purposes in the practice of optometry in accordance
with Section 40-37-105(A). In this subsection,
"pharmaceutical agent" means anesthetics, mydriatics,
cycloplegics, miotics, dyes, and over-the-counter drugs.
(B) Licensed pharmacists may sell pharmaceutical agents, other
than Schedule I and Schedule II controlled substances as defined in
Section 44-53-110, to optometrists who are therapeutically certified
by the South Carolina Board of Examiners in Optometry for
diagnostic and therapeutic purposes in the practice of optometry in
accordance with Section 40-37-105(B).
SECTION 40-43-160. Every pharmacist or other person selling
any nonlegend poison must be satisfied that the purchase is made
for legitimate purposes and keep a book on file in which must be
recorded every sale of the following articles: arsenic and its
preparations, all metallic cyanides and cyanides of potassium, tartar
emetic, corrosive sublimate, aconite and its preparations, strychnine
and all other poisonous alkaloids, and their salts, and hydrocyanic
acid. The record must exhibit the name of the person to whom the
poison was sold, his place of residence, quantity of poison sold, and
the purpose of purchase as stated. The book or file must be kept at
all times subject to inspection of the coroner of the county and the
solicitor or inspector of the Board of Pharmacy or any other person
as either of them may designate.
These above-named poisons, and oxalic acid, chloroform, or any
other poisonous articles that may be added to the list by the board,
must be securely labeled "POISON" when sold in the
drug outlet.
Nothing in this section may be construed to apply to the filling of
prescriptions made by physicians.
SECTION 40-43-170. [Section repealed]
SECTION 40-43-180. It shall be unlawful for any person to
deliver prescription drugs to any drugstore, pharmacy or other
establishment which dispenses prescription drugs at any time when
such establishments are not open for business, unless shipments are
received by an employee of such establishments.
SECTION 40-43-190. Any person violating the provisions of
Section 40-43-180 shall be deemed guilty of a misdemeanor and
upon conviction shall be fined in an amount not to exceed five
thousand dollars or punished for a term not to exceed two years.
SECTION 40-43-200. Notwithstanding any other provision of
law or regulation pharmacies and apothecaries are hereby permitted
to advertise the retail price of all drugs sold by prescription.
SECTION 40-43-210. Nothing in this chapter applies to the
manufacture or sale, at wholesale or retail, of packaged, bottled, or
nonbulk chemicals, drugs, medicines, medical and dental supplies,
cosmetics, and dietary foods when identified by and sold under a
trademark, trade name, or other trade symbol privately owned or
registered in the United States Patent Office, sold, or offered for
sale to the general public, if the articles meet the requirements of
the Federal Food, Drug and Cosmetic Act.
This chapter does not apply to the manufacture or sale, at
wholesale or retail, of insecticides, fungicides, rodenticides, weed
killers, detergents, or commonly used household chemicals of a
nonmedical nature.
SECTION 40-43-220. [Section repealed]
SECTION 40-43-230. (A) License renewal forms must be
mailed to the last known address of every person holding a current
license as a pharmacist or an assistant pharmacist before December
first of each year. The completed license renewal form, the license
renewal fee, and any other documentation that may be required
must be returned to the board on or before January first of each
year.
(B) The board, upon application and payment of the applicable
renewal fee of seventy dollars, may issue an inactive status license
to a licensed pharmacist who is not actively engaged in the practice
of pharmacy in this State, pursuant to this chapter. The pharmacist's
license renewal certificate must be prominently marked as an
inactive license, and the holder may not practice pharmacy under
any conditions in this State. If the pharmacist wishes to reactivate
the license, he shall complete the required continuing education for
license renewal, plus an additional fifteen hours which must have
been obtained during the calendar year immediately preceding the
reactivation.
(C) Failure to renew a license by the required date, but before
February first, results in the assessment of a fifty dollar penalty in
addition to the seventy dollar renewal fee. After February first, a
license which has not been renewed is considered a lapsed license.
A person who practices pharmacy with a license that has lapsed is
considered as practicing without a license. Reinstatement of a
lapsed license may be granted upon (1) evidence satisfactory to the
board of good and sufficient grounds for the failure to renew the
license within the prescribed period and (2) payment of the seventy
dollar renewal fee and a penalty of fifty dollars.
SECTION 40-43-235. Whenever any currently licensed
pharmacist or assistant pharmacist changes his mailing address, the
board must be notified in writing within ten days, listing his name,
license number, and new mailing address.
SECTION 40-43-240. Whenever any licensed pharmacist in the
employ of or in charge of the pharmaceutical duties of a drug outlet
within this State leaves the employ of or ceases to have charge of
the pharmaceutical duties of the drug outlet, he shall notify the
secretary of the board in writing within ten days of the change,
giving the name and address of the drug outlet in which his services
have terminated. Whenever any licensed pharmacist within this
State makes any change in his employment from one drug outlet to
another, he shall notify the secretary of the board of the change
within ten days, listing the name and address of the drug outlet in
which he was last employed, and to which he expects to move.
SECTION 40-43-250. The board shall establish and maintain a
register of all drug outlets including, but not limited to, the name,
address, both mailing and actual location, telephone number, the
individual named as permit holder, the pharmacists-in-charge or
consultant pharmacist and all pharmacists and assistant pharmacists
employed at the location, and any other pertinent information.
The board shall maintain a register of all pharmacists and
assistant pharmacists licensed in this State including, but not limited
to, the name of the person licensed, license number, current place
of employment, current mailing and home addresses, and any other
pertinent information.
SECTION 40-43-260. (A) The board, after a hearing and upon
proof that grounds exist, may order the revocation or suspension of
a license, publicly or privately reprimand the holder of a license, or
take any other reasonable action short of revocation or suspension,
such as requiring the licensee to undertake additional professional
training subject to the direction and supervision of the board. The
board may also impose restraint upon the practice of the licensee as
circumstances warrant until the licensee demonstrates to the board
adequate professional competence. In addition to any other sanction
imposed by the board upon the licensee, the board may require the
licensee to pay a civil penalty of up to one thousand dollars to the
board for each violation of this chapter or of the regulations
promulgated by the board, but the total penalty or fine for the
violations may not exceed ten thousand dollars. All fines must be
remitted to the State Treasurer and deposited in a special fund from
which the board must be reimbursed for administrative costs for
each case upon the approval of the Budget and Control Board. At
any time when this fund exceeds twenty thousand dollars, all excess
funds must be remitted to the General Fund. Fines are payable
immediately upon the effective date of discipline. Interest accrues
after fines are due at the maximum rate allowed by law. No
licensee against whom a fine is levied is eligible for reinstatement
until the fine has been paid in full. Any action of the board
relating to the revocation or suspension of a license, or other action
either restricting a license or limiting or otherwise disciplining a
licensee, must be taken only after a written complaint of misconduct
has been filed with the board in accordance with the
Administrative Procedures Act and regulations promulgated by the
board. If a complaint is not dismissed, in accordance with
subsection (B), a hearing must be held.
(B) Upon its review, the board may either dismiss the complaint
or find that the licensee is guilty of misconduct meriting sanction.
In either event, the board shall file a final certified report of the
proceedings before it with the secretary of the board and the
secretary shall notify the complainant and the licensee and their
counsel of the action.
(C) A decision by the board to revoke, suspend, fine, or
otherwise restrict a license or limit or otherwise discipline a licensee
must be by majority vote of the board members and is subject to
review by an administrative law judge as provided under Article 5
of Chapter 23 of Title 1 upon petition filed by the licensee with the
administrative law judge and a copy served upon the secretary of
the board within thirty days from the date of delivery of its decision
to the licensee. The review is limited to the record established by
the board hearing.
(D) A decision by the board to revoke, suspend, fine, or
otherwise restrict a license or limit or otherwise discipline a licensee
becomes effective upon delivery of a copy of the decision to the
licensee and a petition for review by an administrative law judge
does not operate as a supersedeas.
(E) Misconduct, which constitutes grounds for revocation,
suspension, fine, or other restriction of a license or a limitation on
or other discipline of a licensee is satisfactory showing to the board
of any of the following:
(1) that a false, fraudulent or forged statement or document has
been used or a fraudulent, deceitful or dishonest act has been
practiced by the holder of a license in connection with a licensing
requirement;
(2) that the holder of a license has been convicted of a felony
or any other crime involving fraud, drugs, or any of the laws
relating to controlled substances, intoxicating liquors, or the
unlawful sales of dangerous drugs as prohibited by the Federal
Food, Drug and Cosmetic Act;
(3) that the holder of a license uses alcohol or drugs to such a
degree as to render him unfit to practice pharmacy;
(4) that the holder of a license has been convicted of the illegal
or unauthorized practice of pharmacy;
(5) that the holder of a license has knowingly performed an act
which in any way assists an unlicensed person to violate any
provisions of the pharmacy laws;
(6) that the holder of a license has sustained any physical or
mental disability, as determined by a physician, which renders
further practice by him dangerous to the public;
(7) that the holder of a license is guilty of engaging in
dishonorable, unethical, or unprofessional conduct that is likely to
deceive, defraud, or harm the public;
(8) that the holder of a license is guilty of the use of any
intentionally fraudulent statement in any document connected with
the practice of pharmacy;
(9) that the holder of a license is guilty of obtaining fees or
assisting in obtaining fees under intentionally fraudulent
circumstances;
(10) that the holder of a license has intentionally violated or
attempted to violate, directly or indirectly, or is assisting in or
abetting the violating or conspiring to violate any provisions or
terms of this chapter or any regulations promulgated under this
chapter;
(11) that the holder of a license has been found by the board
to lack the ethical or professional competence to practice pharmacy;
(12) that the holder of a license has practiced pharmacy while
under the influence of alcohol, drugs, or other intoxicants.
(F) In addition to all other remedies and actions incorporated in
this section, the license of a pharmacist adjudged mentally
incompetent by a court of competent jurisdiction must be
automatically suspended by the board until the pharmacist is
adjudged by a court of competent jurisdiction or in any other
manner provided by law as being restored to mental competency.
The board may refuse to grant a license to practice pharmacy to
any person, otherwise qualified, upon any of the grounds for which
a license can be revoked or suspended.
SECTION 40-43-270. Acts or omissions by a licensee causing
the denial, revocation, suspension, or restriction of a license to
practice pharmacy in another state support the issuance of a formal
complaint and the commencement of disciplinary proceedings as set
forth in Section 40-43-260. This provision applies only when the
disciplinary action taken in another state is based on grounds that
would constitute misconduct under Section 40-43-260.
Proof of the acts or omissions may be shown by a copy of the
transcript of record of the disciplinary proceedings in the other state
or a copy of the consent order or similar final order stating the
basis for the action taken.
Upon the filing of an initial complaint alleging that the licensee
has been disciplined in another state, the licensee shall produce for
the board copies of all transcripts, documents, and orders used,
relied upon, or issued by the licensing authority in the other state.
Failure to produce these items within ninety days of the board's
request for them must result in the suspension of the individual's
license to practice pharmacy in this State until the items are
supplied to the board.
The licensee may present mitigating evidence to the board
regarding disciplinary action taken in another state or evidence that
the acts or omissions committed in another state do not constitute
misconduct under Section 40-43-260.
SECTION 40-43-280. On July first in every presidential
election year the Governor, upon the recommendation of a majority
of the Board of Pharmacy, shall appoint and commission a chief
drug inspector, who must be a licensed pharmacist and continues in
office at the discretion of the board. The chief drug inspector is the
executive director of the board and qualifies by taking the usual
oath of office.
SECTION 40-43-290. [Section repealed]
SECTION 40-43-300. The chief drug inspector or his designee,
who must be an employee of the Board of Pharmacy, shall visit
annually all of the drug outlets in this State and inspect them to see
that the laws relating to the licensing of pharmacists and assistant
pharmacists are obeyed and to see that all of the provisions of this
chapter are obeyed and carried out by the drug outlets, pharmacists,
and assistant pharmacists of this State. If any violation of this
chapter is discovered, the inspector either shall require the
pharmacist, assistant pharmacist, or permit holder of the drug outlet
in default immediately to correct the violation or shall prosecute the
offender under the law, using his discretion after consulting with
the board if considered necessary. The inspector or his designee
may swear out warrants for offenders who violate the provisions of
this chapter.
SECTION 40-43-310. [Section repealed]
SECTION 40-43-320. A person who violates a provision of
this chapter is guilty of a misdemeanor and, upon conviction, must
be fined not more than five hundred dollars or imprisoned not more
than two years, or both.
SECTION 40-43-330. The Board of Pharmacy, through its
solicitor or chief drug inspector, or otherwise, as may be most
expedient, may prosecute all persons violating the provisions of this
chapter.
SECTION 40-43-340. [Section repealed]
SECTION 40-43-350. [Section repealed]
SECTION 40-43-360. (A) For the purposes of Sections
40-43-360 to 40-43-460, "drug outlet" means any outlet
for the sale, distribution, or dispensing of drugs bearing the legend
"Caution - federal law prohibits dispensing without a
prescription" including, but not limited to, pharmacies
(institutional or community, public or private), nursing homes,
hospitals, convalescent homes, extended care facilities, family
planning clinics, public or private health clinics, infirmaries,
wholesalers, correctional institutions, industrial health clinics which
possess legend drugs, mail order vendors, and manufacturers within
this State.
(B) For the purposes of this section, medical practitioners
dispensing drugs in the treatment of their patients and pharmacists
are not considered drug outlets. The distribution of complimentary
drug samples by manufacturer's representatives to pharmacists
licensed to dispense and to practitioners in this State who are
legally authorized to prescribe does not require a permit for a drug
outlet within the meaning of this chapter.
(C) "Pharmacy" means an outlet dispensing drugs on
the order of a practitioner licensed to prescribe drugs.
"Practitioner" means a physician, dentist, osteopath,
podiatrist, nurse practitioner, physician's assistant, therapeutically
certified optometrist, or veterinarian licensed by any state or
territory (other than pharmacists engaged in the practice of
pharmacy) to prescribe with regard to drugs or devices in the course
of professional practice or research. Nothing in this section
supersedes the Nursing Dispensing Act, Section 40-33-30.
(D) A physician may dispense noncontrolled prescription drugs
at an entity that provides free medical services if no pharmacist is
available. All noncontrolled prescription drugs must be labeled as
required by Section 39-23-55.
SECTION 40-43-370. It is unlawful for any person to operate
any drug outlet within this State without having obtained a permit
to do so from the Board of Pharmacy.
The board may issue a special permit for a limited medical care
institution which must be based on special conditions of use
imposed by the board. A policy and procedure manual detailing the
type and method of operation, hours of operation, and the method
of documentation of continuing pharmacist control shall accompany
the application for this permit. The issuance and continuation of
these permits are subject to compliance with the conditions set forth
by the board.
The application for all permits must be made on a form to be
prescribed by the board and accompanied by the required fee.
If it is desired to operate more than one drug outlet, separate
applications must be made and separate permits issued for each.
Regional health services districts operated by the South Carolina
Department of Health and Environmental Control are required to
have only one permit for each district. A pharmacist may supervise
no more than two adjacent districts and has full responsibility for
drug distribution and dispensing in those districts.
Hospital pharmacies must be directed by a pharmacist who is
knowledgeable in the specialized functions of institutional
pharmacy. For the purposes of dispensing to hospital inpatients, a
licensed pharmacist may supervise a number of ancillary pharmacy
personnel to be determined by the pharmacist in charge and the
hospital administrator.
SECTION 40-43-380. On evidence satisfactory to the board (a)
that the drug outlet for which the permit is sought will be
conducted in full compliance with the statutory laws pertaining to
pharmacy; and (b) if the drug outlet is a pharmacy, that the
pharmacy constantly will be under the personal and immediate
supervision of a licensed pharmacist, or assistant pharmacist, as
prescribed by Section 40-43-120, a permit must be issued to
persons the board considers qualified to conduct the drug outlet,
after an inspection of the premises of the proposed drug outlet by a
board inspector.
If an application is refused, the board shall notify the applicant in
writing of its decision and the reasons for its decision.
Permits issued under the provisions of Sections 40-43-360 to
40-43-460 must be displayed in a conspicuous place in the drug
outlet for which it was issued. The permits are not transferable,
expire on the last day of June following the date of issue, and must
be renewed annually.
SECTION 40-43-390.Application blanks for renewal permits
must be mailed by the Board to each permit holder on or before
May first in each year, and if application for renewal is not made
on or before the following first day of June, the existing permit
shall lapse on the date of its expiration, and no renewal permit may
be granted except: (a) upon evidence satisfactory to the Board of
good and sufficient grounds for the failure to file the application
within the prescribed period; and (b) upon payment of the renewal
fee and a penalty of fifty dollars; however, before assessing any
penalty, the Board shall determine that proper notice of the required
time of permit renewal was given.
The Board is authorized, after notice and opportunity for hearing
to revoke any permit when examination or inspection of the drug
outlet shall disclose that the drug outlet is not being conducted
according to law.
If any permit holder has obtained a permit to operate or maintain
a drug outlet by misrepresentation or fraud, the Board shall cancel
the permit to operate the drug outlet.
If the holder of a permit to operate a drug outlet is convicted in
any state or federal court for violation of any of the laws relating to
narcotic drugs, unlawful sale of intoxicating liquors, or the unlawful
sale or disposition of drugs restricted to sale at retail on the
prescription of a licensed physician, dentist, podiatrist, or
veterinarian; or if any permit holder pleads guilty to or enters a plea
of nolo contendere in any court of competent jurisdiction of a like
violation, the Board may cancel the permit held by the permit
holder.
The Board may revoke, suspend, or refuse to issue or renew the
permit of any drug outlet for any of the following causes:
(1) failure to have or maintain the required qualifications, as
prescribed by Public Health and Pharmacy Laws, for a permit to
operate a drug outlet;
(2) failure to comply with state or federal laws relating to a
drug outlet or the practice of pharmacy;
(3) permitting the license of a licensed pharmacist to be
displayed in any drug outlet where the holder is not in actual and
regular attendance;
(4) retaining as an employee any person who wilfully or
habitually violates any of the state or federal laws applicable to a
drug outlet or its operation.
SECTION 40-43-400. Before any permit shall be revoked or
suspended, the holder thereof shall have notice in writing of the
charge against him at a date specified in such notice, at least five
days after the service thereof, be given a public hearing and have an
opportunity to produce testimony in his favor and confront the
witnesses against him.
SECTION 40-43-410. Any person to whom the Board of
Pharmacy has refused to issue a permit, or whose permit has been
revoked, suspended, or canceled, may appeal from the decision and
order of the board to an administrative law judge as provided under
Article 5 of Chapter 23 of Title 1 at any time within thirty days
after the date of the receipt of the action taken by the board.
No order of revocation, suspension, or cancellation of a permit is
effective until the decision and order become final.
SECTION 40-43-420. The fees for a permit to open a new
pharmacy and for the annual renewal of a permit to operate a
pharmacy must be set by the board in regulation in accordance with
the Administrative Procedures Act.
SECTION 40-43-425. (A) A pharmacy located outside this
State, whose primary business is mail order prescription service,
must have a permit issued by the board to ship, mail, or deliver a
controlled substance or dangerous drug or device into this State
pursuant to a prescription of a licensed practitioner. The pharmacy
shall report to the board:
(1) information on the location, names, and titles of all
principal corporate officers and pharmacists who are dispensing
controlled substances or dangerous drugs or devices to residents of
this State. The report must be updated annually and within thirty
days after a change of permitholder or pharmacist-in-charge;
(2) that it complies with the applicable laws for operation in
the state in which it is located and with the provisions of this
section. The pharmacy shall maintain a valid unexpired license,
permit, or registration in compliance with the laws of the state in
which it is located and must be constantly under the personal and
immediate supervision of a licensed pharmacist. The pharmacy
shall submit to the board with its initial application and with each
renewal application a copy of its most recent inspection report
resulting from an inspection conducted by the regulatory or
licensing agency of the state in which it is located. These
inspections are deemed to meet all inspection requirements
contained in this chapter;
(3) that it maintains its records of controlled substances or
dangerous drugs or devices dispensed to patients in this State so
that the records are readily retrievable.
(B) Nothing in this chapter requires that pharmacists employed
by pharmacies located in other states and who are not engaged in
the practice of pharmacy in this State be licensed in this State.
(C) If the state in which the pharmacy is located does not
establish, by statute or regulation, a ratio describing the number of
auxiliary personnel that a pharmacist may supervise, or otherwise
define the role of the pharmacist in the compounding and
dispensing of prescription drugs, then that pharmacy must not allow
a pharmacist to supervise more than one supportive person at any
one time in the compounding and dispensing of prescription drugs.
(D) A pharmacy, as described in this section, during its regular
hours of operation but not less than six days nor forty hours a
week, shall provide a toll-free telephone service to facilitate
communication between patients in this State and a pharmacist at
the pharmacy who has access to their records. This telephone
number must be printed on a label affixed to the container for the
substance, drug, or device.
(E) An application for a pharmacy permit under the provisions of
this section must be made on a form furnished by the board, signed
by a responsible person who has been designated as the
permitholder, and accompanied by the required fee. The board may
require information from the pharmacy reasonably necessary to
carry out the purposes of this section. Each pharmacy shall apply
individually and obtain a separate permit for each location. The
permit is not transferable and expires annually. An application
blank for a renewal permit must be mailed by the board to each
permitholder before May second each year, and if application for
renewal is not made before the following June second, the existing
permit lapses on the date of its expiration, and no renewal permit
may be granted except:
(1) upon evidence satisfactory to the board of good and
sufficient grounds for the failure to file the application within the
prescribed period;
(2) upon payment of the renewal fee and a penalty of fifty
dollars.
(F) The board may deny, revoke, suspend, or otherwise take
action against a pharmacy permit issued under the provisions of this
section for:
(1) failure to comply with the requirements of:
(a) this section;
(b) Sections 40-43-150, 40-43-400, 40-43-410, and
40-43-420;
(c) board Regulations 99-2, 99-27, 99-33, and 99-38;
(d) Subchapter 1, Chapter 13, Title 21 of the U. S. Code,
the Federal Controlled Substance Act; or
(e) Chapter 2, Title 21 of the Code of Federal Regulations,
the Federal Controlled Substance Regulation;
(2) conduct which causes serious bodily or serious
psychological injury to a resident of this State if the board has
referred the matter to the regulatory or licensing agency under
which the pharmacy operates in the state in which it is located and
that agency fails to initiate an investigation within forty-five days of
the referral. The board shall maintain a record of referrals pursuant
to this item and action taken on them.
The board annually shall furnish each pharmacy permitholder
with a current copy of the sections and regulations listed in item
(1).
(G) A pharmacy required to obtain a permit pursuant to this
section but not issued a permit, may not advertise its services in this
State, nor may a resident of this State advertise the services for the
pharmacy.
(H) A permit issued pursuant to this section is not evidence that
the pharmacy is doing business within this State.
SECTION 40-43-430. Nothing in Sections 40-43-360 to
40-43-460 shall be construed as preventing any duly licensed
physician, dentist, podiatrist or veterinarian from dispensing his
own drugs in the regular course of his professional practice; nor in
any manner interfering with or to require a permit for the sale or
offering for sale of patent, proprietary or commonly used medicines
and remedies as are sold by general stores; nor to prevent or
interfere with the sale of such acids, poisons or chemicals as are
used in insecticides or in agriculture.
Provided, further, that nothing in Sections 40-43-360 to
40-43-460 shall be construed as preventing any hospital licensed by
the State Department of Health and Environmental Control, or
owned or operated by an agency of the State or the United States
of America, from dispensing drugs to in-patients in the regular
course of operation of such hospital.
SECTION 40-43-440. Any person violating any of the
provisions of Sections 40-43-360 to 40-43-460 shall be guilty of a
misdemeanor and, upon conviction, shall be fined not more than
three hundred dollars for each offense, and each and every day such
violation continues shall constitute a separate and distinct offense.
SECTION 40-43-450. [Section repealed]
SECTION 40-43-460. The number of pharmacists in any given
area must not be considered nor may competition among drug
outlets be considered by the board in determining whether or not to
grant a permit or to revoke, suspend, or cancel a permit.
Section 40-43-10. This chapter may be cited as the `South
Carolina Pharmacy Practice Act'. The purpose of this chapter is to
promote, preserve, and protect the public health, safety, and welfare
by and through the effective control and regulation of the practice
of pharmacy; the licensure of pharmacists; the licensure, permitting,
control, and regulation of all sites or persons, in or out of this State,
that distribute, manufacture, possess, or sell drugs or devices within
this State, and the regulation and control of other materials as may
be used in the diagnosis, treatment, and prevention of injury,
illness, and disease of a patient or other individual. The practice of
pharmacy is an independent professional practice and is not a
subgroup of any other professional practice.
The practice of pharmacy shall center around the provision of
pharmacy care services and assisting the patient to achieve optimal
therapeutic outcomes. The practice of pharmacy means any of the
following health care services provided by an individual licensed by
the South Carolina Board of Pharmacy: advising and consulting
concerning therapeutic value, content, hazards and appropriate use
of drugs, diagnostics, and devices; initiating or modifying of drug
therapy in accordance with written protocols or guidelines in
collaboration with a practitioner authorized to independently
prescribe drugs or devices; selecting drugs; participating in drug
utilization reviews; storing prescription drugs and devices; ordering
lab work in accordance with written guidelines or protocols in
collaboration with a practitioner authorized to order lab work;
providing patient counseling; the compounding, dispensing, and
labeling of drugs or devices; interpreting and evaluating
prescriptions; administering and distributing drugs and devices;
maintaining prescription drug records; supervising pharmacy interns,
externs, and technicians; other acts, services, operations, or
transactions necessary or incidental to the conduct, operation,
education, management, and control of pharmacy; and any other
services defined by the Board of Pharmacy. A pharmacist
providing the above services, which constitutes primary care, must
not be precluded from being compensated for the services.
If a provision of this chapter is declared unconstitutional or
illegal, or the applicability of this chapter to a person, pharmacy, or
circumstance is held invalid by a court of competent jurisdiction,
the constitutionality or legality of the remaining provisions of this
chapter and the application of this chapter to other persons,
pharmacies, and circumstances are not affected and shall remain in
full force and effect without the invalid provision or application.
Section 40-43-20. Except as otherwise provided in this chapter,
it is unlawful for an individual to engage in the practice of
pharmacy unless currently licensed pursuant to this chapter.
Section 40-43-30. For purposes of this chapter:
(1) `Administer' means the direct application of a drug or
device pursuant to a lawful order of a practitioner to the body of a
patient by injection, inhalation, ingestion, topical application, or any
other means.
(2) `Biological safety cabinet' means a containment unit suitable
for the preparation of low-to-moderate risk agents where there is a
need for protection of the product, personnel, and environment,
according to National Sanitation Foundation Standard 49.
(3) `Board' or `Board of Pharmacy' means the South Carolina
State Board of Pharmacy.
(4) `Brand name' means the proprietary or trade name placed
upon a drug, its container, label, or wrapping at the time of
packaging.
(5) `Class 100 Environment' means an atmospheric environment
which contains less than one hundred particles 0.5 microns in
diameter per cubic foot of air.
(6) `Collaborative Pharmacy Practice' is that practice of
pharmacy whereby a pharmacist has jointly agreed, on a voluntary
basis, to work in conjunction with one or more practitioners
authorized to independently prescribe drugs to safely and effectively
manage a patient's drug therapy regimen under a protocol whereby
the pharmacist may perform certain functions authorized by the
practitioner or practitioners under certain specified conditions or
limitations, or both.
(7) `Compounding' means the preparation, propagation,
conversion, or processing of a drug or device, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis, or the
preparation, mixing, assembling, packaging, or labeling of a drug or
device as the result of a practitioner's prescription drug order or
initiative based on the practitioner/patient/pharmacist relationship in
the course of professional practice, or for the purpose of, or as an
incident to, research, teaching, or chemical analysis and not for sale
or dispensing. Compounding also includes the preparation of drugs
or devices in anticipation of prescription drug orders based on
routine, regularly observed prescribing patterns.
(8) `Confidential information' means information maintained in
a patient's records or which is communicated to a patient as part of
patient counseling, which is privileged and may be released only to
the patient, to those practitioners and pharmacists where, in the
pharmacist's professional judgment, release is necessary to protect
the patient's health and well being, and to other persons or
governmental agencies authorized by law to receive such
confidential information.
(9) `Cytotoxic agent' means a drug that has the capability of
killing living cells.
(10) `Deliver' or `Delivery' means the actual, constructive, or
attempted transfer of a drug or device from one person to another,
whether or not for consideration.
(11) `Designated agent' means a person employed by an
authorized practitioner to transmit, either orally or electronically, a
prescription drug order on behalf of the authorized practitioner to
the pharmacist. The authorized practitioner accepts the
responsibility for the correct transmission of the prescription drug
order.
(12) `Designated pharmacist' means an individual currently
licensed by the Board of Pharmacy in this State who certifies
internship training.
(13) `Device' means an instrument, apparatus, implement,
machine, contrivance, implant, or other similar or related article,
including any component part or accessory, which is required under
federal law to bear the label: `Caution: Federal law restricts this
device for sale by or on the order of a _________', the blank to be
filled with the word physician, dentist, veterinarian, or with the
descriptive designation of any other practitioner licensed by the law
of the State in which he practices to use or order the use of the
device; or ` Federal law prohibits dispensing without prescription';
or any products deemed to be a public health threat after notice and
public hearing as designated by the board.
(14) `Dispense' means the transfer of possession of one or more
doses of a drug or device by a licensed pharmacist or person
permitted by law, to the ultimate consumer or his agent pursuant to
a lawful order of a practitioner in a suitable container appropriately
labeled for subsequent administration to, or use by, a patient. As an
element of dispensing, the dispenser shall, before the actual physical
transfer, interpret and assess the prescription order for potential
adverse reactions or side effects, interactions, allergies, dosage, and
regimen the dispenser considers appropriate in the exercise of his
professional judgment, and the dispenser shall determine that the
drug or device called for by the prescription is ready for dispensing.
The dispenser shall also provide counseling on proper drug usage,
either orally or in writing, as provided in this chapter. The actual
sales transaction and delivery of a drug or device is not considered
dispensing and the administration is not considered dispensing.
(15) `Distribute' means the delivery of a drug or device other
than by administering or dispensing.
(16) `Drug' or `Medicine' means:
(a) articles recognized as drugs in an official compendium, or
supplement to a compendium, designated from time to time by the
board for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in human or other animals;
(b) articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in human or other animals;
(c) articles, other than food, or nonprescription vitamins
intended to affect the structure or a function of the human body or
other animals; and
(d) articles intended for use as a component of any articles
specified in item (a), (b) or (c) of this subsection.
(17) `Drug regimen review' includes, but is not limited to, the
following activities:
(a) evaluation of the prescription drug orders and pharmacy
patient records for:
(i) known allergies;
(ii) rational therapy-contraindications;
(iii) reasonable dose and route of administration; and
(iv) reasonable directions for use.
(b) evaluation of the prescription drug orders and pharmacy
patient records for duplication of therapy.
(c) evaluation of the prescription drug orders and pharmacy
patient records for interactions:
(i) drug-drug;
(ii) drug-food;
(iii) drug-disease, if available; and
(iv) adverse drug reactions.
(d) evaluation of the prescription drug orders and pharmacy
patient records for proper utilization, including over-utilization or
under-utilization, and optimum therapeutic outcomes.
(18) `Enteral' means within or by way of the intestine.
(19) `Equivalent drug product' means a drug product which has
the same established name and active ingredients to meet the same
compendia or other applicable standards, but which may differ in
characteristics such as shape, scoring configuration, packaging,
excipient (including colors, flavors, preservatives), and expiration
time. Pharmacists may utilize as a basis for the determination of
generic equivalency Approved Drug Products with Therapeutic
Equivalence Evaluations and current supplements published by the
Federal Food and Drug Administration, within the limitations
stipulated in that publication.
(20) `Extern' means an individual currently enrolled in an
approved college or school of pharmacy who is on required
rotations for obtaining a degree in pharmacy.
(21) `Generic names' mean the official compendia names or
United States Adopted Names (USAN).
(22) `Institutional facility' means an organization whose primary
purpose is to provide a physical environment for patients to obtain
health care services.
(23) `Institutional Pharmacy' means the physical portion of an
institutional facility that is engaged in the compounding, dispensing,
and distribution of drugs, devices, and other materials, hereinafter
referred to as `drugs', used in the diagnosis and treatment of injury,
illness, and disease and which is permitted by the State Board of
Pharmacy.
(24) `Institutional consultant pharmacist' means a pharmacist
licensed in this State who acts as a consultant for institutional
facilities.
(25) `Intern' means an individual who is currently registered by
certificate in this State to engage in the practice of pharmacy while
under the personal supervision of a pharmacist and is satisfactorily
progressing toward meeting the requirements for licensure as a
pharmacist.
(26) `Labeling' means the process of preparing and affixing a
label which includes all information required by federal and state
law to a drug container exclusive of the labeling by a manufacturer,
packer, or distributor of a nonprescription drug or commercially
packaged legend drug or device.
(27) `Manufacturing' of products means the production,
preparation, propagation, conversion, or processing of a drug or
device, either directly or indirectly, by extraction from substances
of natural origin or independently by means of chemical or
biological synthesis, or from bulk chemicals, and includes any
packaging or repackaging of the substances or labeling or relabeling
of its container, if these actions are followed by the promotion and
marketing of the drugs or devices for resale to pharmacies,
practitioners, or other persons.
(28) `Manufacturer' means a person engaged in the manufacture
of prescription drugs or devices.
(29) `Medical order' means a lawful order of a practitioner which
may or may not include a prescription drug order.
(30) `Nonprescription drug' means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws of this State and
the federal government.
(31) `Nonresident pharmacy' means a pharmacy located outside
this State.
(32) `Parenteral' means a sterile preparation of drugs for
injection through one or more layers of the skin.
(33) `Patient counseling' means the oral or written
communication by the pharmacist to a patient or care giver
providing information on the proper use of drugs and devices.
(34) `Permit consultant pharmacist'" means a pharmacist
licensed in this State who acts as a consultant for a permit holder
other than a pharmacy or institution.
(35) `Person' means an individual, sole-proprietorship,
corporation, partnership, association, or any other legal entity
including government.
(36) `Pharmacy care' is the direct provision of drug therapy and
other pharmacy patient care services through which pharmacists, in
cooperation with the patient and other health care providers, design,
implement, monitor, and manage therapeutic plans for the purpose
of improving a patient's quality of life. Objectives include cure of
disease, elimination or reduction of a patient's symptomatology,
arresting or slowing a disease process, or prevention of a disease or
symptomatology. The process includes three primary functions:
(a) identifying potential and actual drug-related problems;
(b) resolving actual drug-related problems; and
(c) preventing potential drug-related problems.
(37) `Pharmacist' means an individual health care provider
licensed by this State to engage in the practice of pharmacy. A
pharmacist is a learned professional authorized to provide patient
care services within the scope of their knowledge and skills.
(38) `Pharmacist-in-charge' means a pharmacist currently
licensed in this State who accepts responsibility for the operation of
a pharmacy in conformance with all laws pertinent to the practice
of pharmacy and the distribution of drugs and who is in full and
actual charge of the pharmacy and personnel.
(39) `Pharmacy' means a location for which a pharmacy permit
is required and in which prescription drugs and devices are
maintained, compounded, and dispensed for patients by a
pharmacist. This definition includes a location where
pharmacy-related services are provided by a pharmacist.
(40) `Pharmacy technician' means an individual other than an
intern or extern, who works under the personal supervision of a
licensed pharmacist or who handles legend drugs in a pharmacy
department, or both, and who is required to register as a pharmacy
technician.
(41) `Poison' means:
(a) a drug, chemical, substance, or preparation which,
according to standard works on medicine, materia medica, or
toxicology, is liable to be destructive to adult human life in doses of
sixty grains or less; or
(b) a substance recognized by standard authorities on medicine,
materia medica, or toxicology as poisonous; or
(c) any other item enumerated in this chapter; or
(d) a drug, chemical, substance, or preparation which is labeled
`Poison'.
(42) `Possess' in this chapter refers to legend drugs that are not
dispensed pursuant to a prescription drug order.
(43) `Practitioner' means a physician, dentist, therapeutically
certified optometrist, podiatrist, veterinarian, or other health care
provider authorized by law to diagnose and prescribe drugs and
devices.
(44) `Prescription drug' or `legend drug' means:
(a) a drug which, under federal law, is required, prior to
being dispensed or delivered, to be labeled with either of the
following statements:
(i) `Caution: Federal law prohibits dispensing without
prescription';
(ii) `Caution: Federal law restricts this drug to use by, or
on the order of, a licensed veterinarian'; or
(b) a drug which is required by any applicable federal or state
law to be dispensed pursuant only to a prescription drug order or is
restricted to use by practitioners only;
(c) any products considered to be a public health threat, after
notice and public hearing as designated by the board; or
(d) any prescribed compounded prescription is a prescription
drug within the meaning of this act.
(45) `Prescription drug order' means a lawful order from a
practitioner for a drug or device for a specific patient, issued for a
legitimate medical purpose within the prescriber's course of
legitimate practice and including orders derived from collaborative
pharmacy practice.
(46) `Prospective drug use review' means a review of the
patient's drug therapy and prescription drug order before dispensing
the drug as part of a drug regimen review.
(47) `Provider' or `primary health care provider' includes a
pharmacist who provides health care services within the
pharmacist's scope of practice pursuant to state law and regulation.
(48) `Significant adverse drug reaction' means a drug-related
incident that may result in serious harm, injury, or death to the
patient.
(49) `Sterile pharmaceutical' means a dosage form devoid of
viable micro-organisms.
(50) `Therapeutically equivalent' means a drug product with the
same efficacy and toxicity when administered to an individual as
the originally prescribed drug.
(51) `Wholesale distributor' means a person engaged in
wholesale distribution of prescription drugs or devices including,
but not limited to, manufacturers; repackagers; own-label
distributors; private-label distributors; jobbers; brokers; warehouses
including manufacturers' and distributors' warehouses, chain drug
warehouses, and wholesale drug warehouses; independent wholesale
drug traders; and retail pharmacies that conduct wholesale
distributions. `Wholesale distributor' does not include:
(a) intracompany sales, being defined as a transaction or
transfer between a division, subsidiary, parent or affiliated or
related company under the common ownership and control of a
corporate entity;
(b) the purchase or other acquisition by a hospital or other
health care entity that is a member of a group-purchasing
organization of a drug for its own use from the group-purchasing
organization or from other hospitals or health care entities that are
members of such organizations;
(c) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by a charitable organization described in
section 501(c)(3) of the Internal Revenue Code of 1954 to a
nonprofit affiliate of the organization to the extent otherwise
permitted by law;
(d) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care
entities that are under common control. For purposes of this
section, `common control' means the power to direct or cause the
direction of the management and policies of a person or an
organization, whether by ownership of stock, voting rights, by
contract, or otherwise;
(e) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons. For
purposes of this section, `emergency medical reasons' includes the
transfer of legend drugs by a licensed pharmacy to another licensed
pharmacy or a practitioner licensed to possess prescription drugs to
alleviate a temporary shortage, except that the gross dollar value of
the transfers may not exceed five percent of the total legend drug
sales revenue of either the transferor or the transferee pharmacy
during a consecutive twelve-month period;
(f) the sale, purchase, or trade of a drug, an offer to sell,
purchase, or trade a drug, or the dispensing of a drug pursuant to a
prescription; or
(g) the sale, purchase, or trade of blood and blood
components intended for transfusion.
(52) Written guideline or protocol' means an agreement where a
practitioner authorized to independently prescribe drugs and a
pharmacist mutually agree to conduct collaborative pharmacy
practice in an institutional setting or with individual patients in
community settings if a specific protocol agreement is signed and is
filed as required by law or by rule or regulation of the board.
Section 40-43-40. (A) There is created the State Board of
Pharmacy to be composed of eight members, appointed by the
Governor with advice and consent of the Senate, one of whom must
be a lay member from the State at large, one of whom must be a
pharmacist from the State at large, and six of whom must be
pharmacists representing each of the six congressional districts.
(B) The pharmacist at large and the lay member shall serve
coterminously with the appointing Governor and until their
successors are appointed and qualify. The board shall conduct an
election to nominate three pharmacists from each congressional
district to be submitted to the Governor for consideration for
appointment. The Governor shall appoint one pharmacist to
represent each congressional district from among the nominees
submitted for that district. The election shall provide for
participation by all pharmacists currently licensed and residing in
the congressional district for which the nomination is being made.
The pharmacists must be residents of the congressional district they
represent, licensed, in good standing to practice pharmacy in this
State, and actively engaged in the practice of pharmacy in this
State. The members of the board representing the six congressional
districts shall serve terms of six years and until their successors are
appointed and qualify. No member may serve more than two
successive terms of office except that a member serving an
unexpired term may be reelected and reappointed for two successive
terms.
(C) Before December first in the year in which the term expires
for a member representing a congressional district, a qualified
pharmacist desiring to be a candidate for the board shall submit to
the administrator of the board a biography and a petition bearing
the signatures of a minimum of fifteen pharmacists practicing in
that pharmacist's congressional district. The administrator shall
prepare ballots for mailing to all pharmacists licensed and residing
in the congressional district for which the nomination is being
made. The ballots must be in a form so as to make tabulation
quick and easy and shall contain the names of the nominees in
alphabetical order. Enclosures to accompany the ballots shall
include the envelope in which the ballot is to be sealed and an
envelope addressed to the secretary of the board. The addressed
envelope shall contain a statement headed `information required' on
which must be typed or printed the name of the voter and a space
for the voter's signature certifying that the voter:
(1) is the person whose name appears on the statement;
(2) is eligible to vote in this election;
(3) has personally cast the ballot.
(D) All ballots must be mailed by the administrator before
January fifteenth to the last known mailing address of all
pharmacists residing in the congressional district for which the
nomination is being made and must be returned to the administrator
postmarked before February fifteenth and received by the office
before February twenty-fifth. The administrator of the board shall
certify these ballots to be true and valid.
(E) Before March first, the board shall certify in writing to the
Governor the name of the three persons winning the election and
the name of the person the nominee replaces on the board, and the
member, when appointed by the Governor, takes office the first of
July of that year.
(F) Notwithstanding subsection (B), if a nominee is judged unfit
by the Governor, the board must be informed and other nominees
must be submitted in like manner.
(G) Vacancies must be filled in the manner of the original
appointment for the unexpired portion of the term.
(H) The Governor may remove a member of the board who is
guilty of continued neglect of board duties or who is found to be
incompetent, unprofessional, or dishonorable. No member may be
removed without first giving the member an opportunity to refute
the charges filed against that member.
Section 40-43-50. (A) The board is styled `The Board of
Pharmacy' and shall meet in the City of Columbia or any other
place in the State designated by the board at least three times a
year. The board may meet additionally for administrative purposes
at the call of the chairman or of two-thirds of its members.
(B) A simple majority of the appointed members of the board
constitutes a quorum for the transaction of business. The board
shall elect a chairman and a vice-chairman.
Section 40-43-60. (A) There must be an Administrator of the
Board of Pharmacy who must be a pharmacist licensed in the State
of South Carolina and who must be the chief drug inspector. The
responsibility and authority for the programs of the Board of
Pharmacy and the office staff shall rest solely with the
Administrator of the Board of Pharmacy. When a vacancy occurs,
the position of Administrator of the Board of Pharmacy shall be
filled as follows: The Department of Labor, Licensing and
Regulation shall advertise the vacancy in newspapers statewide as
well as in the South Carolina Pharmacy Association Journal. The
members of the Board of Pharmacy shall interview the applicants
and make a recommendation to the director of the department. The
director of the department shall choose the administrator from the
recommendations of the Board of Pharmacy.
(B) The Board of Pharmacy shall have its own staff of
inspectors who must be pharmacists licensed in South Carolina and
shall conduct all pharmacy inspections and investigations and shall
report to and be supervised by the Administrator of the Board of
Pharmacy.
(C) The chief drug inspector, or his designee, shall visit
biennially all permitted facilities in this State and inspect them to
see that the laws relating to the licensing of pharmacists are obeyed
and to see that all of the provisions of this chapter are obeyed and
carried out by the permitted facilities and pharmacists of this State.
If a violation of this chapter is discovered, the inspector either shall
require the pharmacist or permit holder of the permitted facility in
default immediately to correct the violation or shall prosecute the
offender under the law, using his discretion after consulting with
the board if considered necessary. The inspector or his designee
may swear out warrants for offenders who violate the provisions of
this chapter.
(D) Administrative changes that affect the individual integrity of
the board must be approved by the board.
(E) The board shall:
(1) regulate the practice of pharmacy;
(2) regulate the sale and dispensing of drugs, poisons, and
devices;
(3) regulate the employment and training of pharmacy
interns and technicians in pharmacies;
(4) regulate and control the sale, character, and standards of
drugs, poisons, devices, and drugs compounded or dispensed in this
State, secure samples, and prevent the sale and dispensing of such
drugs, poisons, medicines, nonprescription drugs, devices, and new
drugs that do not conform to this chapter, the rules and regulations
promulgated under this chapter, or other laws of this State or the
federal government;
(5) investigate alleged violations of this chapter or any other
law in the State pertaining to, or in connection with, persons or
firms licensed by the board or otherwise authorized by state laws to
manufacture, sell, distribute, dispense, or possess drugs, medicines,
poisons, or devices, or as related to misbranded or counterfeit
drugs, or any regulations promulgated by the board under this
chapter; conduct hearings when, in its discretion, it appears to be
necessary; and bring violations to the notice of the prosecuting
attorney of the court of competent jurisdiction in which a violation
takes place or to the notice of the Attorney General;
(6) establish the minimum specifications for the physical
facilities, technical equipment, environment, supplies, personnel,
and procedures for the storage, compounding or dispensing, or both,
of drugs or devices, and for the monitoring of drug therapy;
(7)confine at any time to prescription order only the dispensing
of a drug found to be potentially dangerous to public safety if
dispensed without prescription.
(8) seize any drugs and devices found by the board to
constitute an imminent danger to the public health and welfare.
(9) promulgate regulations which the board, in its judgment,
considers necessary for the carrying out of the purposes of this
chapter;
(10) license in accordance with this chapter pharmacists who
shall practice in this State and permit all facilities which shall
dispense drugs in this State and to suspend, revoke, or cancel a
license or permit in accordance with law;
(11) adopt rules of professional conduct for pharmacists which
must be appropriate to the establishment and maintenance of a high
standard of integrity and dignity in the profession; and
(12) perform other duties and to have other powers and
authority as may be necessary and proper to accomplish the
foregoing or as may be prescribed by law.
(F) The board may:
(1) join professional organizations and associations organized
exclusively to promote the improvement of the standards of the
practice of pharmacy for the protection of the health and welfare of
the public or whose activities assist and facilitate the work of the
board, or both;
(2) establish a bill of rights for patients concerning the health
care services a patient may expect in regard to pharmacy care.
(G) Notwithstanding anything in this chapter to the contrary,
whenever a duly authorized representative of the board finds, or has
probable cause to believe, that a drug or device is adulterated or
misbranded within the meaning of the Federal Food and Drug Act,
the duly authorized representative of the board shall affix to the
drug or device a tag or other appropriate marking giving notice that
the drug or device is or is suspected of being adulterated or
misbranded, has been detained or embargoed, and warning all
persons not to remove or dispose of the drug or device by sale or
otherwise until provision for removal or disposal is given by the
board, its agent, or the court. No person shall remove or dispose of
the embargoed drug or device by sale or otherwise without
permission of the board or its agent or, after summary proceedings
have been instituted, without permission from the court.
(1) When a drug or device detained or embargoed under
subsection (G) has been declared by a representative to be
adulterated or misbranded, the board shall, as soon as is practical,
petition the court in which jurisdiction the article is detained or
embargoed for an order for condemnation of the article. If the
court determines that the drug or device so detained or embargoed
is not adulterated or misbranded, the board shall direct the
immediate removal of the tag or other marking.
(2) If the court finds the detained or embargoed drug or
device is adulterated or misbranded, the drug or device, after entry
of the decree, must be destroyed at the expense of the owner under
the supervision of a board representative and all costs and fees,
storage, and other proper expense shall be borne by the owner of
the drug or device. When the adulteration or misbranding can be
corrected by proper labeling or processing of the drug or device, the
court, after entry of the decree and after costs, fees, and expenses
have been paid and a good and sufficient bond has been posted,
may direct that drug or device be delivered to the owner for
labeling or processing under the supervision of a board
representative. Expense of the supervision shall be paid by the
owner. The bond shall be returned to the owner of the drug or
device on representation to the court by the board that the drug or
device is no longer in violation of the embargo and the expense of
supervision has been paid.
(3) It is the duty of the Attorney General (State's Attorney)
to whom the board reports any violation of subsection (G) to cause
appropriate proceedings to be instituted in the proper court without
delay and to be prosecuted in the manner required by law. Nothing
in this subitem shall be construed to require the board to report
violations whenever the board believes the public's interest will be
adequately served in the circumstances by a suitable written notice
or warning.
(H) The board may place under seal all drugs or devices that are
owned by or in the possession, custody, or control of a licensee at
the time the license is suspended or revoked or at the time the
board refuses to renew the license. Except as otherwise provided in
this section, drugs or devices so sealed shall not be disposed of
until appeal rights under the Administrative Procedures Act have
expired, or an appeal filed pursuant to that act has been determined.
The court involved in an appeal filed pursuant to the Administrative
Procedures Act may order the board, during the tendency of the
appeal, to sell drugs that are perishable. The proceeds of the sale
must be deposited with that court.
(I) Nothing in this section shall be construed as preventing a
licensed physician, dentist, therapeutically certified optometrist,
podiatrist, or veterinarian from possessing or compounding a drug
or device which is used for administration in the regular course of
patient treatment; or from dispensing drugs or devices in the regular
course of patient treatment that are the lawful property of the
licensed physician, dentist, therapeutically certified optometrist, or
veterinarian; or of a partnership or corporate entity of which the
dispensing physician, dentist, therapeutically certified optometrist,
podiatrist, or veterinarian has a substantial ownership interest.
Drugs or medicine dispensed must comply with the labeling
requirements of this act.
(J) The distribution of complimentary drug samples by
manufacturer's representatives to pharmacists licensed to dispense
and to practitioners In this State who are legally authorized to
prescribe does not require a permit within the meaning of this
chapter.
(K) Nothing in this section prohibits an optometrist from
purchasing, possessing, administering, selling, prescribing, or
dispensing either directly or through a licensed manufacturer contact
lenses, contact lens solutions, and topically applied dyes.
(L) Unless otherwise expressly restricted by this act, nothing in
this act shall prevent, restrict, or otherwise interfere with the sale,
of non-narcotic, nonprescription drugs by a retail merchant.
Section 40-43-80. (A) To obtain a license to engage in the
practice of pharmacy, an applicant for licensure by examination
shall:
(1) have submitted a written application in the form
prescribed by the Board of Pharmacy at least forty-five days before
the advertised date of the licensure examination;
(2) have received a Bachelor of Science in Pharmacy or
Doctor of Pharmacy degree from an accredited college or school of
pharmacy and approved by the Board of Pharmacy or have received
the Foreign Pharmacy Graduate Equivalency Certification. The
accrediting agency may include, but is not limited to, the American
Council on Pharmaceutical Education. The school or college of
pharmacy or department of pharmacy of universities referred to in
this item must be examined and inspected by the Board of
Pharmacy of South Carolina or its accrediting agency and approved
by the board periodically to see that the school or college of
pharmacy of the universities comply with the standards of the board
and its accrediting agency as to the purpose of the college, the
faculty, teaching load, size of classes, curriculum, and degrees,
admission requirements, attendance, promotion and graduation,
student load, instruction, library, administration, finance, physical
plant, extra curricular activities, miscellaneous factors and annual
progress report.
(3) have completed an internship or other program that has
been approved by the Board of Pharmacy, or demonstrated to the
board's satisfaction experience in the practice of pharmacy which
meets or exceeds the minimum internship requirements of the
board;
(4) have successfully passed an examination or examinations
given by the Board of Pharmacy attaining a score of not less than
seventy-five on the National Association of Boards of Pharmacy
License Examination (NABPLEX) and the Drug Law Examination;
(5) have paid all the appropriate fees.
Section 40-43-81. (A) In order for a pharmacist currently
licensed in another jurisdiction to obtain a license as a pharmacist
by license transfer in this State, an applicant shall:
(1) have submitted a written application in the form
prescribed by the Board of Pharmacy at least thirty days prior to the
advertised date of the Pharmacy Law Exam;
(2) have possessed at the time of initial licensure as a
pharmacist all qualifications necessary to have been eligible for
licensure at that time in this State;
(3) have presented to the board proof of initial licensure by
examination and proof that such license is in good standing;
(4) have presented to the board proof that any other license
granted to the applicant by any other state has not been suspended,
revoked, or otherwise restricted for any reason except nonrenewal
or for the failure to obtain the required continuing education credits
in any state where the applicant is currently licensed but not
engaged in the practice of pharmacy;
(5) have paid the fees specified by the board;
(6) all applicants for licensure by reciprocity shall have a law
exam review with members of the board.
(B) No applicant is eligible for license transfer unless the state
in which the applicant was initially licensed as a pharmacist also
grants licensure transfer to pharmacists duly licensed by
examination in this State, under like circumstances and conditions.
Section 40-43-82. (A) The Board of Pharmacy shall register
pharmacy technicians who are performing pharmacy functions under
the supervision of a pharmacist.
(B) Formal academic pharmacy technician training programs that
lead to a certificate, diploma, or higher degree may be approved by
the board if they include at a minimum:
(1) introduction to pharmacy and health care systems;
(2) pharmacy law and ethics;
(3) pharmacy calculations;
(4) pharmacology;
(a) anatomy and physiology;
(b) therapeutic agents;
(c) prescription drugs;
(d) nonprescription drugs;
(5) pharmacy operations;
(a) drug distribution systems;
(b) records management and inventory control;
(c) ambulatory and institutional practice;
(6) compounding;
(a) aseptic technique;
(b) nonsterile compounding;
(7) general education;
(a) medical terminology;
(b) interpersonal relations;
(c) communications;
(d) computers/keyboarding;
(8) problem solving/critical thinking;
(9) experiential training(practical experience).
(C) No pharmacist whose license has been denied, revoked,
suspended, or restricted for disciplinary purposes is eligible to be
registered as a pharmacy technician.
Section 40-43-83. (A) All facilities located within this State,
engaging in the manufacture, production, sale, distribution,
possession, or dispensing of prescription drugs or devices and all
facilities located outside of this State whose primary business is
mail order pharmacy service engaging in the sale, distribution or
dispensing of prescription drugs or devices in this State, must be
permitted by the Board of Pharmacy, and annually shall renew the
permit by June first. Where operations are conducted at more than
one location, each location must be permitted by the Board of
Pharmacy.
(B) Each permittee located outside of this State who ships,
mails, distributes, or delivers prescription drugs or devices in this
State and every pharmacy located outside of this State who ships,
mails, distributes, or delivers prescription drugs or devices in this
State shall designate a registered agent in this State for service of
process. Any such permittee or pharmacy who does not so
designate a registered agent is deemed to have designated the
Secretary of State of this State to be its true and lawful attorney,
upon whom may be served all legal process in any action or
proceeding against such permittee growing out of or arising from
such delivery. A copy of any such service of process shall be
mailed to such permittee or pharmacy by the board by certified
mail, return receipt requested, postage prepaid, at the address such
permittee has designated on its application for licensure in this
State. If any such person is not permitted in this State, service on
the Secretary of State only is sufficient service.
(C) The board shall determine and promulgate the permit
classifications of all permits by regulation under this chapter and
establish minimum standards for such permits as follows:
1) Retail pharmacy;
2) Institutional pharmacy inpatient;
3) NonResident pharmacy;
4) Public health pharmacy;
5) Nuclear pharmacy;
6) Home health pharmacy;
7) Long-term care facility provider;
8) Mail order pharmacy;
9) Family planning clinics;
10) Public health nondispensing health clinic;
11) Private nondispensing health clinic;
12) Institutional nondispensing health clinic;
13) Durable medical equipment (DME) and devices;
14) Drug wholesalers;
15) Drug manufacturers, in-state;
16) Nondispensing providers of pharmacy care.
(D) Each pharmacy shall have a pharmacist-in-charge.
Whenever an applicable rule requires or prohibits action by a
pharmacy, responsibility is that of the permit holder and the
pharmacist-in-charge of the pharmacy, whether the ownership is a
sole proprietor, partnership, association, corporation, or otherwise.
(E) The board may enter into agreements with other states or
with third parties for the purpose of exchanging information
concerning the permitting and inspection of entities located in this
jurisdiction and those located outside this State.
(F) Permits issued under this section must be displayed in a
conspicuous place in the permitted facility for which it was issued
in such a manner that will enable an interested person to determine
the name of the permittee, permit number, and permit expiration
date. The permits are not transferable.
(G) This section must not be construed as precluding any person
from owning or being a permit holder if all of the dispensing,
compounding and retailing of prescription drugs in it are under the
supervision and direction of a licensed pharmacist.
(H) The Board of Pharmacy may deny or refuse to renew a
permit if it determines that the granting or renewing of such permit
would not be in the public interest. If an application is refused, the
board shall notify the applicant in writing of its decision and the
reasons for its decision.
(I) A permit is required for the sale, distribution, possession, or
dispensing of drugs bearing the legend `Caution: Federal law
prohibits dispensing without a prescription', including, but not
limited to, pharmacies (institutional or community, public or
private), nursing homes, hospitals, convalescent homes, extended
care facilities, family planning clinics, public or private health
clinics, infirmaries, wholesalers, correctional institutions, industrial
health clinics, mail order vendors, and manufacturers within this
State.
(J) The board shall assess a civil penalty in the amount of fifty
dollars for failure to display a permit as required by this section.
Section 40-43-84. (A) All applicants for licensure by
examination shall obtain one thousand five hundred hours of
practical experience in the practice of pharmacy. The board shall
establish certificate requirements for interns and standards for
internship, or any other experiential program necessary to qualify an
applicant for licensure. The board shall issue an intern certificate to
a qualified applicant. No intern may receive credit for practical
experience unless he has been issued a certificate by the board.
Such certificate must be granted only to individuals who have been
accepted by or graduated from an approved college of pharmacy,
but no sooner than three months before beginning pharmacy school.
No credit shall be given for internships worked for more than three
months before beginning pharmacy school or if the student does
not matriculate. A foreign pharmacy graduate may secure a
certificate of registration as a pharmacy intern upon presenting to
the board proof of graduation from a pharmacy school located in a
foreign country and a statement of his intent to complete the
requirements of the Foreign Pharmacy Graduate Equivalency
Examination (FPGEE).
(B) An intern may not represent himself as a pharmacist. The
board shall issue to an intern a certificate for purposes of
identification and verification of his role as an intern. The
internship certificate must be displayed in the pharmacy or site in
which the experience is being gained. No individual who has not
been issued a certificate by the Board as an Intern shall take, use, or
exhibit the title of Intern, or any other term of similar like or
import.
(C) An intern may engage in the practice of pharmacy if such
activities are under the direct supervision of a licensed pharmacist.
A pharmacist must be in continuous personal eye and voice contact
with, and actually giving instructions to, the intern during all
professional activities throughout the entire period of the internship.
The pharmacist shall physically review the prescription drug order
and the dispensed product before the product is delivered to the
patient or the patient's agent. The pharmacist is responsible for the
work of the intern. A pharmacist may not supervise more than one
intern at any one time.
Pharmacy interns shall not be left in sole charge of a
prescription department or other approved site at any time.
Violation of this may result in cancellation of any and all internship
hours toward licensure that may have been accrued by the intern,
and may, in the discretion of the board, cause the board after
sufficient notice to the pharmacy intern, to revoke or suspend the
internship certificate as provided above. The supervising
pharmacist or designated pharmacist may also be subject to
disciplinary action by the board.
An applicant for licensure, who is guilty of compounding or
dispensing a prescription of a practitioner or selling legend drugs or
medicines while not under the supervision of a licensed pharmacist
may be refused licensure.
(D) All interns shall notify the board of any change of
employment or residence address within ten days.
(E) Credit for claims of practical experience required under the
pharmacy laws will not be recognized by the board unless such
claims are corroborated by records on file in the board office,
showing the beginning and ending of the practical experience
claimed as supplied by the applicant during the training period and
by the pharmacist who supervised the practical experience during
the training period.
(F) The pharmacy, site, or program in which practical
experience is being obtained shall have a current, valid pharmacy
permit, as required by this chapter, and the designated pharmacist
shall hold a current, valid license to practice pharmacy.
Section 40-43-96. (A) (1) An intern shall notify the Board of
Pharmacy within ten days after the beginning and again within ten
days after ending of each internship period, on forms provided by
the board, of the identity of the internship site and of the designated
pharmacist. This form must be certified by the designated
pharmacist. The pharmacy intern is responsible for the submission
of the appropriate forms within the time limits as set.
(2) An intern may gain practical experience toward licensure
as a pharmacist in any of the following areas:
(a) retail pharmacy (community, independent or chain,
out-patient clinic, and family practice) dispensing prescriptions;
(b) institutional pharmacy (hospital or nursing home);
(c) summer internship program sponsored by the National
Pharmaceutical Council (NPC);
(d) pharmaceutical industry;
(e) nuclear pharmacy;
(f) Veterans Administration or other federal agency
pharmacy or program;
(g) research project in the pharmaceutical sciences;
(h) graduate teaching assistant in college of pharmacy; or
(i) other site or program as approved by the board.
Approval of all experience gained is left to the discretion of the
board after receiving a description of the experience by the intern
and designated pharmacist.
(3) Where practical experience is gained in a pharmacy, other
site, or program located outside of the State, the board has the
discretion to determine whether such experience meets the
requirements of the board. The applicant shall submit from the
secretary of the Board of Pharmacy of the state in which practical
experience was gained certification of the validity of the supervising
pharmacists license and the pharmacy permit.
(4) A minimum of five hundred hours of practical experience
must be obtained in a retail or institutional pharmacy.
(5) A maximum of five hundred hours of internship credit
may be given for participation in an externship program approved
by a recognized college of pharmacy. Hours earned must be
certified by the college of pharmacy, none of which may be used to
fulfill the requirement in subsection (A)(2)(c). The pharmacy at
which an intern is being trained shall provide an environment that is
conducive to the learning of the practice of pharmacy by an intern.
It is expected that the intern will be exposed to all facets of the
practice of pharmacy in that setting, including but not limited to:
(a) evaluation of prescription drug orders;
(b) preparation and labeling of drugs;
(c) dispensing of drugs;
(d) patient profile update and review;
(e) drug use review;
(f) patient counseling; and
(g) proper and safe storage of drugs.
(6) Students enrolled in an approved doctor of pharmacy
program consisting of six or more years of collegiate studies may
receive internship credit for up to one thousand hours for practice
related experiences upon completion of such program the number of
hours certified by the college of pharmacy, none of which shall be
used to fulfill the requirements in subsection (A)(2)(c).
(7) A pharmacy, site, or program offering interns practical
experience toward licensure as a pharmacist shall conform to the
best traditions of pharmacy, shall have available all necessary
reference works, in addition to the official standards and current
professional journals and periodicals, and must be operated at all
times under the supervision of a licensed pharmacist as required by
law. The designated pharmacist must signify willingness to train
interns desiring to obtain practical experience in accordance with
this chapter.
(8) No more than forty hours per week of internship training
may be allowed.
Section 40-43-86. (A) A pharmacy, at a minimum, shall:
(1) be of sufficient size to allow for the safe and proper
storage of prescription drugs and for the safe and proper
compounding and preparation of prescription drug orders;
(2) maintain an area designated for the provision of patient
counseling services. This area must be designed to provide a
reasonable expectation of privacy;
(3) maintain on file current drug reference materials. The
references should enable the user to find information using the
brand name, generic name, pharmacologic group, therapeutic group
and synonym.
(4) update drug monographs monthly, which include the
following prescribing information: actions, indications,
contradictions, warning and precautions, drug interactions, adverse
reactions, patient information, overdosage, administration and
dosage.
(5) update this product information monthly:
(a) products grouped by dosage or strength;
(b) identical brand name products;
(c) distributor name;
(d) package sizes for all dosage forms;
(e) product identification;
(f) whether prescription or nonprescription;
(g) controlled substance schedule;
(h) combination products comparison;
(i) products with identical formulations.
(6) update new development information monthly:
(a) significant recent drug therapy developments;
(b) information on investigational agents;
(c) recent new product information and product listing
changes.
(7) maintain a copy of Equivalent Drug Product Evaluations;
(8) have a current copy of the South Carolina Pharmacy
Practice Act, South Carolina Controlled Substances Act and
Regulations, South Carolina Drug Act, and South Carolina Board of
Pharmacy Newsletter;
(9) maintain patient-oriented reference material for guidance
in proper drug usage;
(10) maintain storage areas at temperatures which shall ensure
the integrity of the drugs prior to their dispensing as stipulated by
the USP/NF and/or the Manufacturer's or distributor's labeling.
(11) have access to a sink with hot and cold running water that
is in the compounding area.
(12) have a pharmacist who, while on duty, is responsible for
the security of the pharmacy department including provision of
effective control against theft or diversion of drugs or devices, or
both.
(13) have secured its pharmacy by either a physical barrier
with suitable locks or an electronic barrier, or both, to detect entry
at a time the pharmacist is not present. The barrier must be
approved by the Board of Pharmacy before being put into use.
(14) display, when the pharmacy department is closed or in the
absence of the licensed pharmacist, a sign stating `Pharmacy
Department Closed, Pharmacist Not On Duty' displayed during the
absence of the licensed pharmacist.
(15) carry, utilize, and maintain according to manufacturer's
specifications the equipment and supplies necessary to conduct a
pharmacy in a manner that is in the best interest of the patients
served and to comply with all state and federal laws;
(16) obtain a sanitation of prescription department permit and
the area and equipment in which prescriptions are compounded and
dispersed must be maintained in a clean and orderly condition and:
(a) the prescription department must be kept dry and well
ventilated, free from obnoxious odors, and equipped with adequate
lighting facilities;
(b) drugs, pharmaceuticals, and chemicals must be arranged
in a neat, orderly manner, free from dust, insects, rodents, or any
type of contamination;
(c) all outdated, damaged, defaced, or unlabeled drugs,
pharmaceuticals, biologicals, and chemicals must be removed from
active stock;
(d) pharmaceuticals and biologicals requiring refrigeration
must be kept stored in a refrigerator at the specified temperature;
(e) all stocks and materials used in the compounding of
prescriptions must be labeled and conform in purity and strength as
required by law;
(f) the prescription counter area upon which prescriptions
are compounded must be used for no other purpose than for
compounding prescription;
(g) the prescription department shall maintain only such
instruments, equipment, materials, drugs, pharmaceuticals,
biologicals, chemicals, and medicines as are necessary in the
compounding and dispensing of prescriptions and pharmaceutical
preparations;
(h) all instruments, articles, and containers used in the
compounding and dispensing of prescriptions and pharmaceutical
preparations must be clean and free form all foreign substances;
(i) the sink, with hot water connection, of the prescription
department must be used for no other purpose than for cleaning of
instruments and materials used in the compounding and dispensing
of prescriptions and medicines, or the cleansing of the hands of
those preparing and compounding;
(j) all pharmacists, before compounding prescriptions, and
supportive personnel assisting pharmacists, shall thoroughly cleanse
their fingernails and wash their hands;
(k) the storing of drugs, medicines, pharmaceuticals, or
consumable materials used in compounding and dispensing
prescriptions and pharmaceutical preparations in the washroom or
toilet of a pharmacy is prohibited.
(B) (1) No person may operate a pharmacy without a
pharmacist-in-charge. The pharmacist-in-charge of a pharmacy
must be designated in and sign the application for the pharmacy
permit, and in each renewal thereof. A pharmacist may not serve
as pharmacist-in-charge unless he is physically present in the
pharmacy a sufficient amount of time to provide supervision and
control. A pharmacist may not serve as pharmacist-in-charge for
more than one pharmacy at any one time without written permission
from the board.
(2) Each institutional pharmacy shall be directed by a
pharmacist, hereinafter referred to as the pharmacist-in-charge who
is licensed to engage in the practice of pharmacy in this State.
(3) The pharmacist-in-charge shall have the following
responsibilities:
(a) developing and/or implementing quality assurance
programs for pharmacy services designed to objectively and
systematically monitor and evaluate the quality and appropriateness
of patient care, pursue opportunities to improve patient care, and
resolve identified problems. Quality assurance programs shall be
designed to prevent and detect drug diversion;
(b) establishing or implementing, or both, written policies
and procedures for the procurement, storage, security, and
disposition of drugs and devices;
(c) establishing or implementing, or both, written policies
and procedures for the provision of pharmacy services;
(d) assuring that all pharmacists, technicians, and interns
employed at the pharmacy are currently licensed, certified, or
registered and that interns and technicians wear proper identification
while on duty;
(e) notifying the Board of Pharmacy immediately of any of
the following changes:
(i) change of employment or responsibility as the
pharmacist-in-charge;
(ii) change of ownership of the pharmacy;
(iii) change of address of the pharmacy; or
(iv) permanent closing of the pharmacy.
(f) making or filing any reports required by state or federal
laws and regulations;
(g) responding to the Board of Pharmacy regarding any
violations brought to the pharmacist-in-charge's attention.
(4) The pharmacist-in-charge must be assisted by a sufficient
number of licensed pharmacists and registered pharmacy technicians
as may be required to competently and safely provide pharmacy
services.
(a) The pharmacist-in-charge shall maintain and file with
the Board of Pharmacy, on a form provided by the board, a current
list of all pharmacy technicians assisting in the provision of
pharmacy services.
(b) The pharmacist-in-charge shall develop and implement
written policies and procedures to specify the duties to be
performed by pharmacy technicians. The duties and responsibilities
of these personnel shall be consistent with their training and
experience. These policies and procedures shall, at a minimum,
specify that pharmacy technicians are to be personally supervised by
a licensed pharmacist who has the ability to control and who is
responsible for the activities of pharmacy technicians, and that
pharmacy technicians are not assigned duties that may be performed
only by a licensed pharmacist. One pharmacist may not supervise
more than two pharmacy technicians at a time. In pharmacy
practice sites where other licensed health care professionals are
authorized to administer drugs, the full-time
pharmacist-to-technician ratio may not exceed a one-to-two ratio.
(5) The pharmacist-in-charge shall develop or implement, or
both, a procedure for proper management of drug recalls which may
include, where appropriate, contacting patients to whom the recalled
drug products have been dispensed.
(6) The pharmacist-in-charge shall establish or implement, or
both written policies and procedures for provision of drugs and
medical staff and other authorized personnel whenever a licensed
pharmacist is not physically present in an institutional facility by
use of night cabinets and/or by access to the pharmacy. A licensed
pharmacist must be on call at all times.
a) In the absence of a pharmacist, only specifically
authorized personnel shall have access by key or combination to the
night cabinets. Such enclosures, which are to be located outside of
the pharmacy, must be sufficiently secure to prevent access by
unauthorized persons.
b) The pharmacist-in-charge, in conjunction with the
appropriate committee of the institutional facility, shall develop
inventory listings of those drugs to be included in the cabinet and
determine who may have access, and ensure that:
(i) the drugs are properly labeled;
(ii) only prepackaged drugs are available, in amounts
sufficient for immediate therapeutic requirements;
(iii) whenever access to the cabinet occurs, written
practitioner's orders and proofs of use are provided;
(iv) all drugs therein are inventoried no less than once a
week;
(v) a complete audit of all activity concerning the
cabinet is conducted no less than once a month; and
(vi) written policies and procedures are established to
implement the requirements of this section.
c) If a drug is not available from floor supplies or night
cabinets, and the drug is required to treat the immediate needs of a
patient whose health would otherwise be jeopardized, the drug may
be obtained from the pharmacy only by authorized personnel.
Removal of a drug from the pharmacy must be recorded on a
suitable form showing patient name, room number, name of drug,
strength, amount, date, time, and signature of authorized personnel.
The form must be left with the container from which the drug was
removed and must be reviewed by a licensed pharmacist within
twenty-four hours.
(d) For an institutional facility that does not have an
institutional pharmacy, drugs may be provided for use by authorized
personnel in emergency kits located at the facility. The kits must
meet the following requirements:
(i) emergency kit drugs must be those drugs which may
be required to meet the immediate therapeutic needs of patients and
which are not available from any other authorized source in
sufficient time to prevent risk of harm to patients by delay resulting
from obtaining the drugs from the other sources;
(ii) all emergency kit drugs must be provided and sealed
by a pharmacist;
(iii) the supplying pharmacist and the medical staff of the
institutional facility shall jointly determine the drugs, by identity
and quantity, to be included in emergency kits;
(iv) emergency kits must be stored in secured areas to
prevent unauthorized access, and to ensure a proper environment for
preservation of the drugs within them;
(v) the exterior of each emergency kit must be labeled to
clearly indicate that it is an emergency drug kit for use in
emergencies only. The label shall contain a listing of the drugs
contained in the kit, including name, strength, and quantity of the
contents, and the name, address(es), and telephone number of the
supplying pharmacist;
(vi) drugs must be removed from emergency kits only
pursuant to a valid medical order;
(vii) whenever an emergency kit is opened, the
supplying pharmacist must be notified and the pharmacist shall
restock and reseal the kit within a reasonable time to prevent risk of
harm to patients; and
(viii) the expiration date of an emergency kit is the
earliest date of expiration of a drug or device supplied in the kit.
Upon the occurrence of the expiration date, the supplying
pharmacist shall replace the expired drug or device.
(C) Except for a pharmacy or a wholesaler, every holder of a
permit from the board shall designate a pharmacist duly licensed by
the Board of Pharmacy as a consultant pharmacist to be responsible
for the duties as stated in this chapter at the permit holder's
location. The consultant pharmacist shall sign a new or renewal
application along with the permit holder and agree in writing to
assume the responsibilities of consultant pharmacist.
(1)The consultant pharmacist must be consistent with the
accepted standards of professional conduct and practice and
responsible for compliance with all applicable laws and regulations
including:
(a) establishing as applicable to the permit, policies, and
procedures for the procurement, storage, compounding, dispensing,
and distribution of drugs;
(b) establishing and supervising the recordkeeping system
for the purchase, sale, possession, storage, safekeeping, and return
of drugs;
(c) facilitating drug recalls and the removal of outdated
and adulterated drugs;
(d) supervising all employees of the permit holder whose
duties relate to the procurement, compounding, sale, distribution,
and storage of drugs;
(e) acting as a drug information resource for the staff by
bringing new and current drug information to their attention and
being available by phone for questions;
(f) performing written monthly inspections that are readily
available.
(2) The outgoing consultant pharmacist and the permit holder
shall notify the board in writing within ten days of a change of
consultant pharmacist.
(3) No designation of an individual as a consultant pharmacist
or delegation of duties to a consultant pharmacist by a holder of a
pharmacy permit shall relieve the permit holder of any of the permit
holder's duties under state or federal laws or regulations.
(D) In addition to the duties and responsibilities contained in this
section, a consultant pharmacist for an institutional facility shall
review the record of each institutional resident receiving medication
for potential adverse reactions, allergies, interactions, and laboratory
test modification and advise the physician of any recommended
changes in the medication regimen. This review must be conducted
monthly and documented on the resident's medical record.
(E) A prescription drug order shall contain at a minimum, the:
(1) full name and address of the patient;
(2) name, address, telephone number, and degree
classification of the prescriber; license number, and Drug
Enforcement Agency registration number of the prescribing
practitioner where required by law;
(3) date of issuance;
(4) name, strength, dosage form, quantity, and indication, if
designated by practitioner, of drug prescribed;
(5) directions for use;
(6) number of refills authorized. No prescription marked
`PRN' or any other nonspecified number of refills may be refilled
more than two years beyond the date it was originally written.
Nothing in this subsection abridges the right of a pharmacist to
refuse to fill or refill a prescription; and
(7) a written order signed by the prescriber, which shall bear
the name of the patient; name, strength, and quantity of the drug or
device prescribed; directions for use; date of issue; and, either
rubber stamped, typed, printed by hand, or typeset, the name,
address, telephone number and degree classification of the
prescriber, and, if a controlled substances is prescribed, the
prescriber's federal registration number;
(8) only one drug and set of instructions for each blank, if
pre-printed.
(F) A prescription drug order must be issued for a legitimate
medical purpose by a practitioner acting within the course of
legitimate professional practice. The prescription drug order must
be received at the pharmacy as it was originally transmitted. Each
prescription drug order becomes part of a permanent record and
must be readily retrievable. The institutional pharmacist must
review the physician's drug order, or a direct copy, prior to
dispensing any drug (except for emergency use). Electronically
transmitted prescription drug orders shall meet these requirements:
(1) must be sent only to a pharmacy of the patient's choice;
(2) must be received at the pharmacy as it was originally
transmitted by facsimile or computer and shall include the name
and address of the practitioner, the phone number for verbal
confirmation, the time and date of transmission, and the name of
the pharmacy intended to receive the transmission, as well as any
other information required by federal or state law;
(3) a pharmacist may dispense prescription drug orders
transmitted electronically only when transmitted by an authorized
practitioner or his designated agent;
(4) the pharmacist shall exercise professional judgment
regarding the accuracy or authenticity of the transmitted prescription
drug order consistent with existing federal or state laws and
regulations.
(5) any alterations of electronic transfer of a prescription drug
order or information constitutes an unlawful act which will be
prosecuted by the Attorney General of this State.
(6) the prescribing practitioner may authorize his agent to
transmit a prescription drug order orally or electronically to the
pharmacy provided that the identity of the transmitting agent is
included in the order.
(G) (1) The one-time transfer of original prescription
information for the purpose of dispensing one refill is permissible
between pharmacies in this State subject to these requirements:
(a) The transfer must be communicated directly between
two pharmacists and not by one pharmacist accessing an
information file containing data for several locations, unless all
locations accessed are under common ownership or accessed
pursuant to contractual agreement of the pharmacies;
(b) The transferring pharmacist shall reduce any remaining
refills by one and so mark the face of the prescription retained by
the transferring pharmacist or record information electronically;
(c) The transferring pharmacist shall record the name and
address of the pharmacy to which the prescription was transferred
and the name of the pharmacist receiving the prescription
information on the reverse side of the transferred prescription or
record information electronically.
(2) The transferring pharmacist shall record the date of the
transfer and the name of the pharmacist transferring the
information;
(3) The transferring pharmacist shall record on the
prescription transferred or record information electronically that the
receiving pharmacist is authorized to dispense one refill based on
the original prescription, if such is the case;
(4) The pharmacist receiving the transferred prescription
information shall record in writing or electronically the following:
(a) the word `transfer' on the face of the transferred
prescription;
(b) any information required to be on a prescription,
including:
(i) the date of issuance of the original prescription;
(ii) the date and time of transfer;
(iii) the pharmacy's name, address, and original
prescription number from which the prescription information was
transferred;
(c) the name of the transferring pharmacist;
(d) the manufacturer or brand name of drug dispensed; and
(e) a statement that the receiving pharmacist shall dispense
only one refill based on the transferring pharmacist's certification
under subsection (G).
(5) The pharmacist receiving the transferred prescription shall
dispense only one refill. The transferring pharmacist shall retain
the original prescription and shall continue to dispense refills up to
the amount for the period authorized less one refill allocated to the
receiving pharmacist.
(6) The requirements of this section may be facilitated by use
of a computer, data, or facsimile.
(7) All records pertinent to this section must be readily
available.
(8) A copy of a prescription issued for restricted drugs must
be given and marked for information only. The copy may not be
dispensed as a prescription. A physician must be contacted for
authorization of the dispensing. This authorization must be handled
in the same manner as an oral or telephone prescription, reduced to
writing, and placed on the prescription file.
(9) Both the original and transferred prescription drug order
must be maintained for a period of two years from the date of last
refill.
(H) (1) Upon receiving a prescription for a brand name
product, a registered pharmacist may in his professional judgment
substitute an equivalent drug product as provided in this subsection.
(2) Every oral or written drug prescription shall provide an
authorization from the practitioner as to whether or not an
equivalent drug product may be substituted.
(3) A written prescription shall have two signature lines at
opposite ends on the bottom of the form. Under the line at the left
side shall be clearly printed the words `Dispense As Written'.
Under the line at the right side shall be clearly printed the words
`Substitution Permitted'. The practitioner shall communicate the
instructions to the pharmacist by signing on the appropriate line.
No written prescription is valid without the signature of the
practitioner on one of these lines.
(4) An oral prescription from the practitioner shall instruct
the pharmacist as to whether or not an equivalent drug product may
be substituted. The pharmacist shall note the instructions on the file
copy of the prescription and retain the prescription form for the
period as prescribed by law.
(5) The pharmacist shall note the brand name or the
manufacturer of the substituted drug dispensed on the file copy of a
written or oral prescription or record this information electronically,
or both. If substitution occurs, the prescription label shall contain
the generic name of the drug dispensed and its manufacturer listed
first followed by the brand name, all to be written in full or
appropriately abbreviated, unless the prescribing practitioner
indicates that the name of the drug may not appear upon the
prescription label.
(6) Substitution may not occur unless the pharmacist advises
the patient or the patient's agent that the practitioner has authorized
substitution and the patient, or patient's agent, consents.
(I) (1) All drugs dispensed for use by inpatients of a hospital
or other health care facility, where the drug is not in the possession
of the ultimate user prior to administration, shall meet these
requirements:
(a) The label of a single unit package of an individual-dose
or unit-dose system of packaging of drugs shall include:
(i) the nonproprietary or proprietary name of the drug;
(ii) the route of administration, if other than oral;
(iii) the strength and volume, where appropriate,
expressed in the metric system whenever possible;
(iv) the control number and expiration date;
(v) special storage conditions, if required.
(b) A log book must be maintained identifying the
repackager, the name of the drug, the lot number, the manufacturer,
the facility control number, the expiration date, the quantity, and the
initials of the pharmacist.
(c) When a multiple-dose drug distribution system is
utilized, including dispensing of single-unit packages, the drugs
must be dispensed in a container to which is affixed a label
containing the:
(i) patient's name;
(ii) date of dispensing;
(iii) nonproprietary or proprietary name of the drug
dispensed, or both; and
(iv) strength, expressed in the metric system whenever
possible.
(2) All drugs dispensed to inpatients for self-administration
shall be labeled in accordance with item (4).
(3) If any drugs are added to parenteral solution, these
admixtures shall bear a distinctive label indicating:
(a) name of solution and volume of solution;
(b) patient's name;
(c) infusion rate;
(d) bottle sequence number or other system control
method;
(e) name and quantity of each additive;
(f) date of preparation;
(g) beyond-use date and time of parenteral admixture;
(h) ancillary precaution labels; and
(i) identity of preparer and checking pharmacist.
(4) All drugs dispensed to ambulatory or outpatients shall
contain a label affixed to the container in which the drug is
dispensed including:
(a) the name and address of the pharmacy dispensing the
drug;
(b) the name of the patient for whom the drug is
prescribed;
(c) the name of the prescribing practitioner;
(d) such directions as may be stated on the prescription
drug order;
(e) the date of dispensing;
(f) any cautions which may be required by federal or state
law;
(g) the serial number of the prescription drug order;
(h) the name or initials of the dispensing pharmacist;
(i) the proprietary or generic name of the drug dispensed
and its strength, if more than one strength of the drug is marketed;
(j) the brand name of the drug product dispensed or the
generic name of the drug product dispensed and its manufacturer or
labeler, either written in full or appropriately abbreviated;
(k) when dispensing a prescribed medication, if a
pharmacist selects an equivalent drug product for a name-brand
prescribed drug, the generic drug name must either be listed on the
prescription label first followed by the name-brand prescribed drug,
or this information must be affixed to the container on an auxiliary
label.
(5) Drugs other than sample medication provided by a
manufacturer to a prescriber for patient use shall meet all
requirements of labeling.
(6) No radiopharmaceutical may be dispensed unless a label
is affixed to the immediate container bearing:
(a) the standard radiation symbol;
(b) the words `Caution--Radioactive Material'; and
(c) the prescription number.
(7) No radiopharmaceutical may be dispensed unless a label
is affixed to the outer or delivery container bearing the:
(a) standard radiation symbol;
(b) words `Caution--Radioactive Material';
(c) radionuclide and chemical form;
(d) activity and date and time of assay;
(e) volume if in liquid form;
(f) requested activity and the calibrated activity;
(g) prescription number;
(h) patient name or space for patient name. Where the
patient's name is not available at the time of dispensing, a
seventy-two hour exemption is allowed to obtain the name of the
patient. No later than seventy-two hours after dispensing the
radiopharmaceutical, the patient's name shall become a part of the
prescription drug order to be retained for two years;
(i) name and address of the nuclear pharmacy;
(j) name of the practitioner; and
(k) lot number of the prescription.
(8) A package prepared by a pharmacist containing two or
more drugs prescribed for a specific patient shall meet USP labeling
requirements.
(J) (1) A pharmacy patient record system must be maintained
by all pharmacies for patients for whom prescription drug orders
are dispensed. The pharmacy patient record system shall provide for
the immediate retrieval of information necessary for the dispensing
pharmacist to identify previously dispensed drugs at the time a
prescription drug order is presented for dispensing. The pharmacist
shall make a reasonable effort to obtain, record, and maintain the:
(a) full name of the patient for whom the drug is
intended;
(b) address and telephone number of the patient;
(c) patient's age or date of birth;
(d) patient's gender;
(e) list of all prescription drug orders obtained by the
patient at the pharmacy during the two years immediately preceding
the most recent entry showing the prescription number, name, and
strength of the drug, the quantity and date received, the number of
refills given, the date of each refill, the identity and quantity of
each refill if different from the prescribed quantity, the identity of
dispensing pharmacist and the name of the practitioner; and
(f) pharmacist comments relevant to the individual's
drug therapy, including any other information peculiar to the
specific patient or drug.
(2) The pharmacist shall make a reasonable effort to obtain
information from the patient or the patient's agent regarding any
known allergies, drug reactions, idiosyncrasies, and chronic
conditions or disease states of the patient and the identity of any
other drugs, including over-the-counter drugs, or devices currently
being used by the patient which may relate to prospective drug
review. This information shall be recorded in the patient's record.
(3) A pharmacy patient record must be maintained for a
period of not less than two years from the date of the last entry in
the profile record. This record may be a hard copy or a
computerized form.
(K) A pharmacist shall review the pharmacy patient record and
each prescription drug order presented for dispensing for purposes
of promoting therapeutic appropriateness by identifying:
(1) over-utilization or under-utilization;
(2) therapeutic duplication;
(3) drug-disease contraindications;
(4) drug-drug interactions;
(5) incorrect drug dosage or duration of drug treatment;
(6) drug-allergy interactions;
(7) clinical abuse/misuse.
Upon recognizing any of the above, the pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, as
appropriate include consultation with the practitioner.
(L)(1) Upon receipt of a new prescription drug order and
following review of the patient's pharmacy record, the pharmacist
shall personally offer counseling to the patient or the patient's
agent. Using his best professional judgment, the pharmacist's
counseling shall include a discussion of those matters that the
pharmacist considers appropriate for the patient or patient's agent in
that particular situation.
The discussion must be in person, whenever practicable, or by
telephone and shall include appropriate elements of patient
counseling. The elements may include:
(a) the name and description of the drug;
(b) the dosage form, dose, route of administration, and
duration of drug therapy;
(c) intended use of the drug and expected action;
(d) special directions and precautions for preparation,
administration, and use by the patient;
(e) potentially serious side effects or interactions and
therapeutic contraindications that may be encountered, including
their avoidance, and the action required if they occur;
(f) techniques for self-monitoring drug therapy;
(g) proper storage;
(h) prescription refill information;
(i) action to be taken in the event of a missed dose; and
(j) pharmacist comments relevant to the individual's drug
therapy, including any other information peculiar to the specific
patient or drug.
(2) Alternative forms of patient information must be used to
supplement patient counseling when appropriate including, but not
limited to, written information leaflets, pictogram labels, and video
programs.
(3) Patient counseling is not be required for inpatients of a
hospital or institution where other licensed health care professionals
are authorized to administer the drug.
(4) A pharmacist is not required to counsel a patient or
caregiver when the patient or caregiver refuses the consultation.
(M) Significant adverse drug reactions must be reported to the
prescriber immediately upon discovery. Appropriate entry on the
patient's record also must be made.
(N) Records of dispensing, which are readily retrievable within
twenty-four hours, for all drugs or devices are to be made and kept
by pharmacies for two years and shall include, but are not limited
to:
(1) quantity dispensed for original and refills, if different
from original;
(2) date of dispensing;
(3) serial number or equivalent if an institution;
(4) the identification of the pharmacist responsible for
dispensing;
(5) name and manufacturer of drug dispensed if drug product
selection occurs; and
(6) records of refills to date.
(O)(1) An up-to-date policy and procedure manual must be
maintained by the pharmacist-in-charge that explains the operational
aspects of an automated system and shall:
(a) include examples of all required output documentation
provided by the automated system;
(b) outline steps to be followed when the automated system
is not operational due to scheduled or unscheduled system
interruption;
(c) outline regular and routine backup file procedure and
file maintenance;
(d) outline audit procedures, personnel code assignments,
and personnel responsibilities;
(e) provide a quality assurance mechanism for data entry
validation.
(2) The automated system shall have the capability of
producing sight-readable information on all original and refill
prescription drug orders. The term `sight-readable' means that an
authorized individual must be able to examine the record and read
the information from the cathode ray tube (CRT), microfiche,
microfilm, printout, or other method acceptable to the Board of
Pharmacy.
The automated system shall provide on-line retrieval (via CRT
display or hard-copy printout) of original prescription drug order
information. The information shall include, but is not limited to,
the prescription drug order requirements and records of dispensing.
The automated system shall have the capability of producing a
printout of any prescription drug order data. The system shall
provide a refill-by-refill audit trail for any specified strength and
dosage form of any drug. The audit trail must be by printout, and
shall include the name of the prescribing practitioner, name and
location of the patient, quantity dispensed on each refill, date of
Dispensing of each refill, name or identification code of the
dispensing pharmacist and unique identifier of the prescription drug
order.
A facility maintaining centralized prescription records must be
capable of sending a requested printout to the pharmacy within
seventy-two hours.
(3) To maintain the confidentiality of patient records, the
system shall have adequate security and systems safeguards to
prevent unauthorized access, modification, or manipulation of
pharmacy patient records. Once the drug has been dispensed, any
alterations in prescription drug order data must be documented
including the identification of the pharmacist responsible for the
alteration.
(4) In the event of an unscheduled system interruption,
sufficient patient data and prescription drug order data must be
available to permit reconstruction of such data within a two-hour
time period for the pharmacist to dispense drugs with sound
professional judgment.
An auxiliary system shall be established for the documentation of
refills if the automated data processing system is inoperative for any
reason and to ensure that all refills are authorized by the original
prescription drug order and that the maximum number of refills is
not exceeded.
The auxiliary system shall be in place to provide for the
maintenance of all necessary patient drug information until the
automated system becomes operational. However, nothing in this
subsection shall preclude the pharmacist from using professional
judgment for the benefit of a patient's health and safety.
When the automated system is restored to operation, the
information regarding prescription drug orders dispensed and
refilled during the inoperative period must be entered into the
automated system.
Routine backup systems and procedures (hard copy, copy, disc,
etc.) must be in place and operational to ensure against loss of
patient data.
In the event that permanent dispensing information is lost due to
unscheduled system interruption, the Board of Pharmacy must be
notified within seventy-two hours of the loss or of the discovery of
the loss.
(P) If a pharmacist receives a request for a prescription refill
and the pharmacist is unable to obtain refill authorization from the
prescriber, the pharmacist may dispense a one-time emergency refill
of up to a seventy-two hour supply of the prescribed medication if:
(1) the prescription is not for a controlled substance;
(2) the medication is essential to the maintenance of life or to
the continuation of therapy;
(3) in the pharmacist's professional judgment, continuing the
therapy for seventy-two hours will produce no undesirable health
consequences or cause physical or mental discomfort;
(4) the pharmacist properly records the dispensing; and
(5) the dispensing pharmacist notifies the prescriber of the
emergency dispensing within seventy-two hours after the one-time
emergency refill dispensing.
(Q) Machines used in the prescription drug distribution process
must be under the control of and are the responsibility of a licensed
pharmacist.
The pharmacist-in-charge shall establish or implement, or both,
written procedures for the safe and efficient distribution of drugs
and for the provision of Pharmacy care. An annual updated copy
of these procedures shall be on hand for inspection by the Board of
Pharmacy.
Drugs brought into an institutional facility by a patient may not
be administered unless they can be identified. If such drugs cannot
be administered, then according to pharmacy procedures specified in
writing, the drugs must be turned into the pharmacy which shall
package and seal them and return them to an adult member of the
patient's immediate family, or store and return them to the patient
upon discharge.
Investigational drugs which are used within an institutional
facility must be stored in and dispensed from the pharmacy only.
All information with respect to investigational drugs must be
maintained in the pharmacy.
All drug storage areas must be routinely inspected by pharmacy
personnel to ensure that no outdated or unusable items are present,
and that all stock items are properly labeled and stored.
A written stop-order policy or other system must be established
by the institutional pharmacists-in-charge to ensure that drug orders
are not inappropriately continued.
There must be a written policy and procedure for providing
pharmacy services in the event of a disaster. This shall be reviewed
annually by all pharmacy staff members and so documented.
(R)(1) it is unlawful for a person, except a pharmacist licensed
under this chapter and pursuant to the regulations of the board of
pharmacy to:
(a) take, use, or exhibit the title `pharmacist', `druggist',
`pharmacy', `drugstore', `drugs', `prescriptions', or any other title,
sign, display, or declaration that tends to lead the public to believe
that the person is engaged in the business of selling, compounding,
or dispensing any prescription drugs; or
(b) have charge of, engage in, or carry on, for himself or
another, the dispensing, compounding, or sale of any prescription
drugs anywhere within this State.
(2) Except as prescribed by this chapter, it is unlawful for a
person to practice as a pharmacist or to advertise or represent
himself by a title, sign, display, declaration, or other item to be a
pharmacist or to engage in, conduct, carry on, or be employed in
the dispensing, compounding, or retailing of any prescription drugs
within this State.
(3) Notwithstanding any other provision of law or regulation,
pharmacies and apothecaries are permitted to advertise the retail
price of all drugs sold by prescription.
(4) Those merchants selling varieties of health and beauty
needs, including that class of personal care products and
nonprescription drugs which do not require a prescription for sale at
retail, may use and display the term `drug-sundries' in advertising,
if these conditions are met:
(a) the word `drug-sundries' is a hyphenated word;
(b) the word `drug-sundries' must appear all on one line;
(c) the two parts of the word must be of equal size
lettering, of the same color, and the same style print or script; and
(d) no effort may be made to mislead the public that there
is a full drug and prescription service available.
(5) Nothing in this section authorizes the board to promulgate
regulations concerning the prices of goods or drugs sold by outlets,
the hours that the business may be operated, or the hours of work
of the employees of the businesses.
(S) Licensed pharmacists may sell pharmaceutical agents, other
than controlled substances as defined in Section 44-53-110, to
optometrists who are diagnostically certified by the South Carolina
Board of Examiners in Optometry for diagnostic purposes in the
practice of optometry in accordance with Section 40-37-105(A).
For purposes of this subsection, `pharmaceutical agent' means
anesthetics, mydriatics, cycloplegias, miotics, dyes, and
over-the-counter drugs.
Licensed pharmacists may sell pharmaceutical agents, other than
Schedule I and Schedule II controlled substances as defined in
Section 44-53-110, to optometrists who are therapeutically certified
by the South Carolina Board of Examiners in Optometry for
diagnostic and therapeutic purposes in the practice of optometry in
accordance with Section 40-37-105(B).
(T)(1) The purpose of collaborative pharmacy practice is to
involve the expertise of the pharmacists in a collaborative effort
with the practitioner and other health care providers to ensure the
highest quality health care services for patients.
(2) A pharmacist, planning to participate in a collaborative
pharmacy practice with a practitioner authorized to independently
prescribe drugs must have on file at his place of practice a properly
prepared written guideline or protocol, which is readily retrievable,
indicating approval has been granted by a practitioner authorized to
independently prescribe. A copy of the written guideline or
protocol also must be on file with the Board of pharmacy, the
Board of Medical Examiners, and the practitioner.
(3) A written guideline or protocol is defined as an agreement
in which a practitioner authorized to independently prescribe legend
drugs may voluntarily delegate to a pharmacist authority to conduct
collaborative pharmacy practice following diagnosis and initial
patient assessment by the practitioner. Any modification of the
written guideline or protocol must be treated as a new protocol. A
written protocol shall include a:
(a) statement identifying the practitioner authorized to
independently prescribe and the pharmacists who are party to the
agreement. The practitioner authorized to independently prescribe
must be in active practice, and the authority agreed upon must be
within the scope of the practitioner's current practice, and the
patients involved must be under the practitioner's direct care;
(b) time period not to exceed two years during which the
written guideline or protocol is in effect;
(c) statement of the type of collaborative pharmacy
practice decisions which the pharmacists are authorized to make
which includes a:
(i) statement of the types of diseases, drugs, or drug
categories involved, and the type of collaborative pharmacy
practice, e.g., modification or initiation of drug therapy, authorized
in each case;
(ii) general statement of the procedures, decision criteria,
or plan the pharmacists are to follow when making therapeutic
decisions. When modification or initiation of drug therapy is
indicated, the practitioner must be notified;
(d) statement of the activities pharmacists are to follow in
the course of exercising collaborative pharmacy practice, including
documentation of decisions made, and a plan for periodic
communication or feedback on the patient to the authorizing
practitioner concerning specific decisions made and any problems or
complications encountered. Documentation may occur on the
prescription record, patient drug profile, patient pharmacy record, or
in a separate log book;
(e) requirement that a pharmacist must have demonstrated
knowledge and competence in performing specific acts of
collaborative pharmacy practice under a protocol which has been
authorized by a practitioner who can independently prescribe;
(f) requirement that adequate supervision by the
practitioner be given, including the responsibility for formulation of
protocols and periodically reviewing protocols and services
provided to patients under the protocols;
(g) requirement that the practitioner must be available
through direct telecommunication with the pharmacist for
consultation, assistance, and direction.
(4) A protocol may not permit the delegation of medical
diagnosis.
(U) Duties that must be performed by a licensed pharmacist or a
pharmacy intern or extern within the practice of pharmacy include,
but are not limited to:
(1) the interpretation and evaluation of medical orders;
(2) participation in drug and device selection;
(3) provision of patient counseling;
(4) performing drug regimen reviews;
(5) provision of pharmacy care; and
(6) receiving telephone or verbal medical orders from
licensed practitioners.
A licensed pharmacist shall supervise the activities of a pharmacy
technician to ensure all activities are performed completely, safely,
and without risk of harm to patients.
Only a licensed pharmacist shall enter into collaborative
pharmacy practice agreements.
(V) Nonprescription drugs which can be sold by all retailers in
the manufacturer's original package, also may be prescribed and
dispensed by pharmacists. When dispensed by a pharmacist, the
drug must be treated in all respects as a prescription drug and all
prescription drug counseling and labeling requirements apply.
(W) A manufacturer or wholesaler shall supply insulin only to
persons or entities that can legally possess prescription drugs.
(X) The American Pharmaceutical Association Code of Ethics
must be adopted as the code of ethics for pharmacists in this State.
(Y) Physicians who are in charge or who directly supervise the
operation of emergency rooms may dispense legend drugs in order
to meet the immediate needs of the patient. The amount dispensed
may not exceed an amount equal to a seventy-two hour supply.
Records of drugs dispensed must be maintained. A valid
physician-patient relationship shall exist between the emergency
room physician and the patient before dispensing legend drugs in
the emergency room.
(Z) It is unlawful for a person to deliver prescription drugs to
any permitted facility, at any time when the facility is not open for
business, unless shipments are received by an authorized employee
of the facility or into a secure area, or both.
(AA) A current record showing disposition of all restricted
pharmaceutical preparations, such as federal legend drugs, exempt
class V, insulin, controlled substances, poisons and any other drugs
so designated by the board, dispensed or sold to physicians,
dentists, veterinarians, pharmacies, hospitals or other persons
authorized by law to possess drugs restricted to sale on prescription
only, must be maintained for two years in the prescription files or
in the records of the permitted facility showing the name of the
person to whom dispensed or sold, the name, strength, and quantity
dispensed or sold and the date of the transaction.
Every pharmacist or other person selling nonlegend poison must
be satisfied that the purchase is made for legitimate purposes and
keep a book on file in which must be recorded every sale of the
following articles: arsenic and its preparations, all metallic cyanides
and cyanides of potassium, tartar emetic, corrosive sublimate,
aconite and alkaloids, and their salts, and hydrocyanic acid. The
record shall exhibit the name of the person to whom the poison was
sold, and the purpose of purchase stated. The book or file must be
kept at all times subject to inspection of the coroner of the county
and the solicitor or inspector of the Board of Pharmacy or any other
person as either of them may designate.
These above-named poisons, and oxalic acid, chloroform, or any
other poisonous articles that may be added to the list by the board,
must be securely labeled `Poison' when sold in the permitted
facility.
Nothing in this section may be construed to apply to the filling of
prescriptions written by physicians.
(BB) No pharmacist or permit holder shall reuse, sell, or offer
for sale a prescription or other medication intended for internal or
external use which has been returned unless the pharmacist
accepting the medication determines in his best professional
judgment that the strength, potency, and stability of the medication
have not been adversely affected or contaminated.
(CC) The fees for a permit to open a new pharmacy and for the
annual renewal of a permit to operate a pharmacy must be
promulgated by the board in regulation in accordance with the
Administrative Procedures Act. The following fees are in effect
until these fees are promulgated in regulation:
(1) one hundred dollars for a permit to open a new pharmacy;
(2) fifty dollars for the annual renewal of a permit to operate
a pharmacy.
(DD)(1) The provisions of this subsection only apply to the
compounding of medication by pharmacies permitted in the State of
South Carolina.
(2) The following are the minimum current good
compounding practices for the preparation of medications by
pharmacists licensed in the State for dispensing or administering, or
both, to humans or animals:
(a) Pharmacists engaged in the compounding of drugs shall
operate in conformance with applicable laws regulating the practice
of pharmacy;
(b) Based on the existence of a
pharmacist/patient/practitioner relationship and the presentation of a
valid prescription, or in anticipation of prescription medication
orders based on routine, regularly observed prescribing patterns,
pharmacists may compound, for an individual patient medications
that are commercially available in the market place;
(c) Pharmacists shall receive, store, or use drug substances
for compounding that meet official compendia requirements, or of a
chemical grade in one of the following categories: chemically pure
(CP), analytical reagent (AR), American Chemical Society (ACS),
or, if other than this, drug substances which in the professional
judgment of the pharmacists are obtained from acceptable and
reliable alternatives;
(d) Pharmacists may compound drugs before receiving a
valid prescription based on a history of receiving valid prescriptions
that have been generated solely within an established
pharmacist/patient/practitioner relationship, for all such products
compounded at the pharmacy as required by the Board of
Pharmacy;
(e) Pharmacists may not offer compounded medications to
other pharmacies for resale; however, practitioners may obtain
compounded medications to administer to patients. Compounding
pharmacies/pharmacists may advertise or otherwise promote the fact
that they provide prescription compounding services, e.g.,
chemicals, devices, and information, when requested; however, they
may not solicit business by promoting to compound specific drug
products, e.g., like a manufacturer;
(f) The compounding of inordinate amounts of drugs in
anticipation of receiving prescriptions without a historical basis of
the distribution of inordinate amounts of compounded products and
without a patient/practitioner/pharmacist relationship is considered
manufacturing;
(3) Pharmacists engaging in compounding shall maintain
proficiency through current awareness and training. Continuing
education shall include training in the art and science of
compounding and the rules and regulations of compounding.
Pharmacy technicians may assist the pharmacist in compounding.
The pharmacist is responsible for training and monitoring the
pharmacy technician. The pharmacy technician's duties must be
consistent with the training received.
Personnel engaged in the compounding of medications shall wear
clean clothing appropriate to the operation being performed.
Protective apparel, such as coats, jackets, aprons, gowns, hand or
arm coverings, or masks must be worn as necessary to protect
personnel from chemical exposure and medication or chemical
contamination.
Only personnel authorized by the responsible pharmacist may be
in the immediate vicinity of the drug compounding operation. A
person shown at any time, either by medical examination or
pharmacist determination, to have an apparent illness or open
lesions that may adversely affect the safety or quality of a drug
product being compounded must be excluded from direct contact
with components, medication containers, closures, in-process
materials, and medication products until the condition is corrected
or determined by competent medical personnel not to jeopardize the
safety or quality of the products being compounded. All personnel
who assist the pharmacists in compounding procedures must be
instructed to report to the pharmacist any health conditions that may
have an adverse effect on drug products.
(4) Pharmacists engaging in compounding shall have a
specifically designated and adequate area (space) for the orderly
compounding of prescriptions that is maintained in a good state of
repair for the placement of material and equipment. Sterile
compounding must be performed in a separate area in compliance
with Section 40-43-88.
Bulk medications and other chemicals or materials used in the
compounding of medication must be stored in adequately labeled
containers in a clean, dry, and temperature-controlled area or, if
required, under proper refrigeration.
Adequate lighting and ventilation must be provided in all drug
compounding areas. Potable water must be supplied under
continuous positive pressure in a plumbing system free of defects
that could contribute contamination to a compounded drug product.
Adequate washing facilities, easily accessible to the compounding
areas of the pharmacy, must be provided. These facilities shall
include, but are not limited to, hot and cold water, soap or
detergent, and air-dryers or single-use towels.
The area used for the compounding of drugs must be maintained
in a clean and sanitary condition. It must be free of infestation by
insects, rodents, and other vermin. Trash must be held and
disposed of in a timely and sanitary manner. Sewage and other
refuse in and from the pharmacy and immediate medication
compounding areas must be disposed of in a safe and sanitary
manner.
If sterile products are being compounded, the pharmacist shall
comply with Section 40-43-88 as applicable to the procedure.
If radio pharmaceuticals are being compounded, the pharmacist
shall comply with Section 40-43-87 as applicable to the procedure.
If drug products with special precautions for contamination, such
as penicillin, are involved in a compounding procedure, appropriate
measures, including either the dedication of equipment or
meticulous cleaning of contaminated equipment before its use for
the preparation of other drugs, must be utilized in order to prevent
cross-contamination.
(5) Equipment and utensils used for compounding must be of
appropriate design and capacity and stored in a manner to protect
from contamination. In addition, all equipment and utensils must
be cleaned and sanitized before use to prevent contamination that
would alter the safety or quality of the drug product beyond that
desired. The pharmacist is responsible for determining suitability
for use. In the case of sterile compounding, the pharmacist shall
comply with Section 40-43-88 as applicable to equipment and
utensils.
Automatic, mechanical, electronic, or other equipment used in
compounding must be routinely inspected, calibrated, if necessary,
or checked to ensure proper performance.
The pharmacist shall ensure that the proper container is selected
to dispense the finished compounded prescription, whether sterile or
nonsterile.
(6) The pharmacist shall ensure that there are formulas and
logs maintained either electronically or manually. Formulas must
be comprehensive and include ingredients, amounts, methodology,
and equipment, if needed, and special information regarding sterile
compounding.
The pharmacist shall ensure that components used in
compounding are accurately weighed, measured, or subdivided as
appropriate at each stage of the compounding procedure to conform
to the formula being prepared. Any chemical transferred to a
container from the original container must be labeled with the same
information as on the original container and the date of transfer
placed on the label.
The pharmacist shall establish and conduct procedures so as to
monitor the output of compounded prescriptions, i.e., capsule
weight variation, adequacy of mixing, clarity, pH of solutions, and,
where appropriate, procedures to prevent microbial contamination of
medications purported to be sterile.
(7) The pharmacist shall label any excess compounded
product so as to reference it to the formula used and the assigned
control number and the estimated beyond-use date based on the
pharmacist's professional judgment, appropriate testing, or
published data. The product must be stored appropriately.
At the completion of compounding the prescription, the
pharmacist shall examine the prescription for correct labeling.
(8) The pharmacist shall keep records of all compounded
products for a period of time as other prescriptions as required by
the Board of Pharmacy. These records must be readily available
for authorized inspection during the retention period at the
establishment. These records are subject to duplication by
photocopying or other means of reproduction as part of the
inspection.
(EE) Unprofessional conduct includes, but is not limited to, the
following acts by a pharmacist, permit holder, pharmacy technician,
or the owner of a permitted facility:
(1) publishing or circulating false, misleading, or otherwise
deceptive statements concerning the practice of pharmacy;
(2) attempting to circumvent the patient counseling
requirements, or discouraging the patient from receiving patient
counseling concerning their prescription drug orders;
(3) divulging or revealing to unauthorized persons patient
information or the nature of professional pharmacy services
rendered without the patient's express consent, or without order or
direction of a court. Authorized persons include:
(a) a patient, or patient's agent, or another pharmacist
acting on behalf of a patient;
(b) the practitioner who issued the prescription drug order;
(c) certified/licensed health care personnel who are
responsible for the care of the patient;
(d) an inspector, agent, or investigator of the Board of
Pharmacy or any federal, state, county, or municipal officer whose
duty is to enforce the laws of this State or the United States relating
to drugs or devices and who is engaged in a specific investigation
involving a designated person or drug;
(e) an agency of government charged with the
responsibility of providing medical care for the patient upon written
request by an authorized representative of the agency requesting the
information.
(4) selling, giving away, or otherwise disposing of
accessories, chemicals, or drugs or devices found in illegal drug
traffic when the pharmacist knows or should have known of their
intended use in illegal activities;
(5) engaging in conduct likely to deceive, defraud, or harm
the public, or demonstrating a wilful or careless disregard for the
health, welfare, or safety of a patient, or engaging in conduct which
substantially departs from the standards of care ordinarily exercised
by a pharmacist;
(6) selling a drug for which a prescription drug order from a
practitioner is required without having received a prescription drug
order for the drug;
(7) wilfully and knowingly failing to maintain complete and
accurate records of all drugs received, dispensed, or disposed of in
compliance with the federal laws and regulations and state laws and
regulations;
(8) obtaining any remuneration by fraud, misrepresentation,
or deception;
(9) using a system providing for the electronic transfer of
information that infringes on a patient's freedom of choice as to the
provider of pharmacy care.
Section 40-43-87. (A) Nuclear/radiologic pharmacy practice
refers to a patient-oriented service that embodies the scientific
knowledge and professional judgment required to improve and
promote health through the assurance of the safe and efficacious use
of radio pharmaceuticals and other drugs. Nuclear/radiologic
pharmacies also shall adhere to the regulations established by the
Nuclear Regulatory Commission as they pertain to the practice of
nuclear pharmacy.
The pharmacist-in-charge of a nuclear pharmacy must be a
qualified nuclear pharmacist. All personnel performing tasks in the
preparation and distribution of radio pharmaceuticals and ancillary
drugs must be under the direct supervision of a qualified nuclear
pharmacist.
(B) Revocation of the radioactive materials license from the
Department of Health and Environmental Control voids the
pharmacy permit immediately and the permit must be returned to
the board within ten days.
(C) Copies of all regulatory inspection reports must be made
available upon request for board inspection.
(D) The nuclear pharmacist-in-charge shall notify the Board of
Pharmacy by letter of the outcome of any hearings that are
conducted pursuant to citations for violations of state or federal
laws or regulations governing radioactive materials. Notification
must be within thirty days of the date of the hearing.
(E) Space and equipment must be adequate to the scope of
services required and provided. All nuclear pharmacy facilities
shall have a radiopharmaceutical preparations/dispensing area, a
radioactive material shipping/receiving area, and a radioactive waste
decay area. Airflow hoods must be certified annually for operational
efficiency in accordance with federal standards by a qualified
technician and must be recertified each time the hood is moved.
Certification must be attached to the front of the hood and shall
state the date certification was granted. Prefilters must be changed
in accordance with manufacturer's specifications. Changes must be
documented by date and initials. Documentation must be retained
for two years.
(F) For purposes of this section, `qualified nuclear pharmacist'
means a pharmacist who holds a current license issued by the South
Carolina Board, and who is either certified as a nuclear pharmacist
by the Board of Pharmaceutical Specialties, or meets minimal
standards of training for status as an authorized user of radioactive
material, as specified by the Nuclear Regulatory Commission.
Section 40-43-88. (A) The purpose of this section is to provide
standards for the preparation, labeling, and distribution of sterile
products by pharmacies, pursuant to or in anticipation of a
prescription drug order. These standards apply to all sterile
products, notwithstanding the location of the patient, e.g., home,
hospital, nursing home, hospice, or doctor's office.
(B) The pharmacy shall have a separate area designated for
placement of the Class 100 laminar airflow hood, which must:
(1) be constructed so as to allow visual observation;
(2) not be a thruway for traffic;
(3) have walls, floor, ceiling, and work surfaces constructed
of materials that are nonporous and do not produce particulate
matter;
(4) be ventilated in a manner that will not interfere with the
outward flow of air from the hood;
(5) not be used for unpacking bulk supplies;
(6) not be used for storage of bulk supplies and materials;
and
(7) have an eye wash station and sink readily accessible to
the area.
(C)(1) All sterile pharmaceuticals must be prepared within the
airflow hood work surface.
(2) Work surfaces of the airflow hood must be cleaned with
seventy percent isopropyl alcohol or an equivalent disinfectant
every eight-hour work shift and as needed for microbial, drug, and
particulate matter removal. This cleaning must be documented by
date, time and initials. Documentation must be retained for two
years.
(3) The airflow hood must be certified by a qualified
technician every twelve months and must be recertified each time
the hood is moved for operational efficiency in accordance with
federal standards. The certification must be attached to the front of
the hood and shall state the date the certification was performed.
Certification documents must be retained for two years.
(4) The sterile product preparation area must be cleaned and
disinfected weekly with appropriate agents according to written
policy and procedures. This must be documented by date and
initials and retained for two years.
(5) Prefilters must be changed in accordance with
manufacturer's specifications. Changes must be documented by
date and initials and documentation must be retained for two years.
(6) Work surfaces inside the airflow hood must be clear of
drugs, records, labels, and equipment unrelated to work in process.
(7) All solutions, additive and nonadditive, must be checked
by a pharmacist before dispensing. The checking pharmacist's
initials must appear on either the prescription or medical order, the
patient's profile, a compounding record, or label. Only one system
must be used. Initials may be computer produced or stamped for
solutions containing noncontrolled additives.
(8) Sterile pharmaceuticals returned by an outpatient or the
outpatient's agent must be destroyed. Supplies and equipment
designed by the manufacturer for one time use may not be reused.
Returned sterile pharmaceuticals containing controlled substances
must be destroyed in accordance with federal and state
requirements.
(9) A sink with hot and cold running water readily accessible
to the sterile products preparation area with immediate availability
of germicidal skin cleanser and either a warm air blower or
nonshedding single-use towels for hand drying must be available to
all personnel preparing sterile pharmaceuticals.
(10) Adverse drug reactions sustained by patients must be
documented in the patient's profile. Significant untoward reactions
must be reported to the Food and Drug Administration and the
manufacturer.
(D)(1) Compounding shall involve aseptic manipulations that are
properly and promptly executed.
(2) Closed system transfers must be used in compounding
sterile pharmaceuticals, except for initial withdrawals from ampules.
(a) All container closures shall remain intact throughout
the aseptic process, except for the penetration of sterile,
pyrogen-free, and particulate matter-free needles or cannulas
through the designated stopper or port.
(b) Ancillary devices used to facilitate the transfer,
withdrawal, or delivery of sterile solutions must be sterile, free of
pyrogen and particulate matter, and used in accordance with the
manufacturer's labeled instructions.
(3) Compounded sterile pharmaceuticals must be stored
immediately according to published and professional guidelines.
(4) Administration must be initiated in accordance with
stability standards.
(5) If products are prepared from nonsterile ingredients, these
products must be appropriately sterilized before dispensing.
(E) In addition to reference books currently required in a
pharmacy, at least one current reference on compatibility and
stability of sterile pharmaceuticals must be available.
(F) All sterile pharmaceuticals prepared for dispensing shall
have an adhesive label affixed which shall contain the following:
(1) name, address, and telephone number of pharmacy for
outpatients and name of facility for inpatients;
(2) if additive, the date solution was prepared. Non-additive
solutions must be dated if the manufacturer's protective cover is
removed before dispensing;
(3) name of physician;
(4) name of patient;
(5) room number and bed of patient, if applicable;
(6) serial number of prescription or other identifying number;
(7) if additive solution, the name and amount of additive. If
additives are identified by their generic name the manufacturer must
be identified on either the prescription, the patient's profile, or
compounding record;
(8) name of basic solution;
(9) name or initials of individual preparing sterile
pharmaceutical on either the prescription or medical order, the
patient's profile, compounding record, or label. For solutions
containing non-controlled additives, the initials may be imprinted;
(10) expiration date and, if applicable, the expiration time of
the solution in accordance with the manufacturer's specifications or
research-supported standard of practice;
(11) frequency and rate of administration;
(12) precautionary statements, auxiliary labels, or warning
labels in keeping with current standards or practice;
(13) special handling or storage requirements, or both;
(G) There must be a system for a pharmacist to be available
twenty-four hours a day for a patient, nursing agency, or physician
to which the pharmacy is providing services.
(H) A profile or medical record must be maintained for each
patient. This profile must be maintained for two years after the last
dispensing activity. It shall contain at a minimum:
(1) patient's name, address, telephone number and, if
applicable, the patient's bed or room number;
(2) age or date of birth, weight, height, and sex of patient;
(3) identity of the health care agency, if applicable;
(4) itemization of sterile pharmaceuticals dispensed with
prescription number or other identifying number, including date
dispensed and the name and amount of additives;
(5) drug and food allergies;
(6) primary diagnosis;
(7) prescription and nonprescription drugs and home remedies
the patient is receiving; and
(8) documentation by a pharmacist of the resolution of other
potential drug related problems.
(I) (1) All cytotoxic solutions must be compounded in a Class
II, biological safety cabinet. No other products may be
compounded in this cabinet.
(2) Protective apparel must be worn by personnel
compounding cytotoxic agents including gloves, closed front gowns
with tight cuffs, and masks. Written procedures for handling spills
of cytotoxic agents must be developed.
(3) There must be immediate access to emergency spill
supplies wherever cytotoxic drugs are prepared.
(4) Prepared solutions must be identified with warning labels
in accordance with state and federal requirements.
(5) Prepared solutions must be packaged for handling and
delivery in a manner that minimizes the risk of rupture of the
primary container and insures the stability and potency of the
solution.
(6) Documentation that personnel have been trained in the
compounding, handling, and destruction of cytotoxic agents must be
available. This documentation must be obtained annually.
(7) Documentation that personnel have been informed of the
carcinogenic, mutagenic, and teratogenic nature of the cytotoxic
agents handled must be available. This documentation must be
updated annually by all personnel.
(8) Class II safety cabinets must be certified by a qualified
technician every twelve months and must be recertified each time
the hood is moved for operational efficiency. Earlier recertification
may be required if dictated by federal or state requirements or
manufacturer's specifications due to workload.
(J) All waste materials must be disposed of in accordance with
federal, state, and local requirements.
(K) A policy and procedure manual must be available in the
pharmacy. The manual shall include policies and procedures as
applicable for the following:
(1) quality control;
(2) sterile technique;
(3) destruction of returned solutions;
(4) labeling of injectable solutions;
(5) drug recall procedures;
(6) investigational drugs;
(7) handling and disposal of hazardous waste;
(8) cytotoxic agents;
(9) maintenance of patient profiles; and
(10) material safety data sheets.
(L) When sterile pharmaceuticals are provided to home care
patients, the dispensing pharmacy may supply a nurse with
emergency drugs if a physician has authorized the use of these
drugs by a protocol or prescription drug order for use in an
emergency situation, e.g., anaphylactic shock.
(M) A licensed health care professional may possess
noncontrolled prescribed legend drugs or devices such as water for
injection, normal saline for IV, and heparin flush used in the
administration of sterile pharmaceuticals.
(N) If appropriate, the pharmacist shall demonstrate or document
the patient's training and competency in managing therapy provided
by the pharmacist to the patient in the home environment. A
pharmacist must be involved in the patient training process in any
area that relates to drug compounding, labeling, administration,
storage, stability, compatibility, or disposal. The pharmacist is
responsible for seeing that the patient's competency in the above
areas is reassessed on an ongoing basis.
(O) There must be a documented, ongoing, quality assurance
control program that monitors patient care and pharmacy care
outcomes, including but not limited to:
(1) routine performance of prospective drug use review and
patient monitoring functions by a pharmacist;
(2) patient-monitoring plans that include written outcome
measures and systems for routine patient assessment including, but
not limited to, infection rates, rehospitalization rates, and the
incidence of adverse drug reactions;
(3) documentation of patient training as specified in
subsection (N);
(4) appropriate collaboration with other health care
professionals.
Section 40-43-89. (A)(1) The following information must be
provided to the board with an application for a wholesale distributor
permit, and for any subsequent permit renewals:
(a) name, full business address, and telephone number of
the applicant;
(b) all trade or business names used by the applicant;
(c) addresses, telephone numbers, and the names of contact
persons for the facility used by the applicant for storage, handling,
and distribution of drugs;
(d) the type of ownership or operation, i.e., partnership,
corporation, or sole proprietorship; and
(e) name of the owner and/or operator of the applicant,
including:
(i) if a person, the name, address, and social security
number or date of birth, or both, of the person;
(ii) if a partnership, the name, address, and social
security number or date of birth, or both, of each partner, and the
name of the partnership;
(iii) if a corporation, the name, address, social security
number or date of birth, or both, and title of each corporate officer
and director, the corporate names, the name of the state of
incorporation, and the name of the parent company, if any; the
name, address, and social security number of each shareholder
owning ten percent or more of the voting stock of the corporation,
including over-the-counter stock, unless the stock is traded on a
major stock exchange and not over-the-counter;
(iv) if a sole proprietorship, the full name, address, and
social security number or date of birth, or both, of the sole
proprietor and the name of the business entity.
(2) Changes in any information in this subsection must be
submitted to the Board of Pharmacy within thirty days of the
change.
(3) Pursuant to Section 40-43-83(e) and Section 40-43-90, the
information required for initial permitting or renewal of a permit of
a wholesale distributor must be submitted on forms prepared by the
Board of Pharmacy or by the National Association of Boards of
Pharmacy which shall act as a clearinghouse of applications for the
board and must be submitted to the Board or NABP accompanied
by the applicable fee.
(4) The board may suspend, revoke, deny, or refuse to renew
the permit of wholesale drug distributors other than pharmacies
dispensing or distributing drugs or devices directly to patients.
(B) The licensed wholesale distributor shall employ adequate
personnel with the education and experience necessary to safely and
lawfully engage in the wholesale distribution of drugs.
(C) All facilities where drugs are stored, warehoused, handled,
held, offered, marketed, or displayed shall:
(1) be of suitable size and construction to facilitate cleaning,
maintenance, and proper operations;
(2) have storage areas big enough to provide adequate
lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(3) have a quarantine area for storage of drugs that are
outdated, damaged, deteriorated, misbranded, or adulterated, or that
are in immediate or sealed secondary containers that have been
opened;
(4) be maintained in a clean and orderly condition; and
(5) be free from infestation by insects, rodents, birds, or
vermin of any kind.
(D)(1) All facilities used for wholesale drug distribution must be
secure from unauthorized entry, access from outside the premises
must be kept to a minimum and well-controlled, the outside
perimeter of the premises must be well-lighted, and entry into areas
where prescription drugs are held must be limited to authorized
personnel. (2) All facilities must be equipped with an alarm
system to detect entry after hours.
(3) All facilities must be equipped with a security system that
provides suitable protection against theft and diversion. When
appropriate, the security system shall provide protection against
theft or diversion that is facilitated or hidden by tampering with
computers or electronic records.
(E) All drugs must be stored at appropriate temperatures and
under appropriate conditions in accordance with requirements, if
any, in the labeling of such drugs, or with requirements in the
current edition of an official compendium.
If no storage requirements are established for a drug, the drug
may be held at `controlled' room temperature, as defined in an
official compendium, to help ensure that its identity, strength,
quality, and purity are not adversely affected.
Temperature and humidity must be automatically documented by
electronic recording devices.
The recordkeeping requirements in subsection (I) must be
followed for all stored drugs.
(F) Upon receipt, each outside shipping container must be
visually examined for identity and to prevent the acceptance of
contaminated drugs or drugs that are otherwise unfit for
distribution. This examination must be adequate to reveal container
damage that would suggest possible contamination or other damage
to the contents.
Each outgoing shipment must be carefully inspected for identity
of the drug products and to ensure that there is no delivery of drugs
that has been damaged in storage or held under improper
conditions.
The recordkeeping requirements in subsection (I) must be
complied with for all incoming and outgoing drugs.
(G)(1) Drugs that are outdated, damaged, deteriorated,
misbranded, or adulterated must be quarantined and physically
separated from other drugs until they are destroyed or returned to
their supplier.
(2) A drug whose immediate or sealed outer or sealed
secondary containers have been opened or used must be identified
as such, and must be quarantined and physically separated from
other drugs until they are either destroyed or returned to the
supplier.
(3) If the conditions under which a drug has been returned
cast doubt on the drug's safety, identity, strength, quality, or purity,
the drug must be destroyed or returned to the supplier unless
examination, testing, or other investigation proves that the drug
meets appropriate standards of safety, identity, strength, quality, and
purity. In determining whether the conditions under which a drug
has been returned cast doubt on the drug's safety, identity, strength,
quality, or purity, the wholesale drug distributor shall consider,
among other things, the conditions under which the drug has been
held, stored, or shipped before or during its return and the condition
of the drug and its container, carton, or labeling, as a result of
storage or shipping.
(4) The recordkeeping requirements in subsection (I) must be
complied with for all outdated, damaged, deteriorated, misbranded,
or adulterated drugs.
(H) (1) Wholesale drug distributors shall establish and maintain
inventories and records of all transactions regarding the receipt and
distribution or other disposition of drugs. These records shall
include:
(a) the source of the drugs, including the name and
principal address of the seller or transferor, and the address of the
location from which the drugs were shipped;
(b) the identity and quantity of the drugs received and
distributed or disposed of; and
(c) the dates of receipt and distribution or other disposition
of the drugs.
(2) Inventories and records must be made available for
inspection and photocopying by any authorized official of any
governmental agency charged with enforcement of this chapter for a
period of two years following disposition of the drugs.
(3) Records described in this subsection that are kept at the
inspection site or that can be immediately retrieved by computer or
other electronic means must be readily available for authorized
inspection during the retention period. Records kept at a central
location apart from the inspection site and not electronically
retrievable must be available for inspection within two working
days of a request by an authorized official of any governmental
agency charged with enforcement of this chapter.
(I) Wholesale drug distributors shall establish, maintain, and
adhere to written policies and procedures which shall be followed
for the receipt, security, storage, inventory, and distribution of
drugs, including policies and procedures for identifying, recording,
and reporting losses or thefts, and for correcting all errors and
inaccuracies in inventories. Wholesale drug distributors shall include
in their written policies and procedures:
(1) a procedure whereby the oldest approved stock of a drug
product is distributed first. The procedure may permit deviation
from this requirement if such deviation is temporary and
appropriate;
(2) a procedure to be followed for handling recalls and
withdrawals of drugs. The procedure must be adequate to deal with
recalls and withdrawals due to:
(a) any action initiated at the request of the Food and Drug
Administration or other federal, state, or local law enforcement or
other government agency, including the Board of Pharmacy;
(b) any voluntary action by the manufacturer to remove
defective or potentially defective drugs from the market; or
(c) any action undertaken to promote public health and
safety by the replacing of existing merchandise with an improved
product or new package design;
(3) a procedure to ensure that wholesale drug distributors
prepare for, protect against, and handle any crisis that affects
security or operation of any facility in the event of a strike, fire,
flood, or other natural disaster, or other situations of local, state, or
national emergency;
(4) a procedure to ensure that outdated drugs are segregated
from other drugs and either returned to the manufacturer or
destroyed. This procedure shall provide for written documentation
of the disposition of outdated drugs which must be maintained for
two years after disposition of the outdated drugs.
(J) Wholesale distributors shall establish and maintain a current
list of officers, directors, managers, and other individuals in charge
of wholesale drug distribution, storage, and handling, including a
description of their duties and a summary of their qualifications.
(K) Wholesale distributors shall permit the Board of Pharmacy
and authorized federal, state, and local law enforcement officials to
enter and inspect their premises and delivery vehicles, and to audit
their records and written operating procedures, at reasonable times
and in a reasonable manner, to the extent authorized by law.
Wholesale distributors that deal in controlled substances shall
register with the appropriate state-controlled substance authority and
with the Drug Enforcement Administration, and shall comply with
all applicable state, local, and DEA requirements.
(L) Wholesale distributors are subject to the provisions of any
applicable federal, state, or local laws or regulations that relate to
drug product salvaging or reprocessing.
(M) This chapter may not be construed to prevent licensed
pharmacists from filling, as otherwise provided by law,
prescriptions originating outside the boundaries of this State and
official United States government prescriptions issued by authorized
governmental officials.
(N) (1) A facility located outside this State, whose primary
business is mail order prescription service, shall have a permit
issued by the board to ship, mail, or deliver a controlled substance
or dangerous drug or device into this State pursuant to a
prescription of a licensed practitioner. The facility shall report to
the board:
(a) information on the location, names, and titles of all
principal corporate officers and pharmacists who are dispensing
controlled substances or dangerous drugs or devices to residents of
this State. The report must be updated annually and within thirty
days of a change of permit holder or pharmacist-in-charge;
(b) that it complies with the applicable laws for operation
in the state in which it is located and with the provisions of this
section. The facility shall have a valid unexpired license, permit, or
registration in compliance with the laws of the state in which it is
located and must be constantly under the personal and immediate
supervision of a licensed pharmacist. The facility shall submit to the
board with its initial application and with each renewal application a
copy of its most recent inspection report resulting from an
inspection conducted by the regulatory or licensing agency of the
state in which it is located. These inspections are deemed to meet
all inspection requirements contained in this chapter;
(c) that it maintains its records of controlled substances or
dangerous drugs or devices dispensed to patients in this State so
that the records are readily retrievable.
(2) Nothing in this chapter requires that pharmacists
employed by facilities located in other states and who are not
engaged in the practice of pharmacy in this State be licensed in this
State.
(3) If the state in which the facility is located does not
establish, by statute or regulation, a ratio describing the number of
auxiliary personnel that a pharmacist may supervise, or otherwise
define the role of the pharmacist in the compounding and
dispensing of prescription drugs, then that facility may not allow a
pharmacist to supervise more than two pharmacy technicians at any
time in the compounding and dispensing of prescription drugs.
(4) A pharmacy, as described in this section, during its
regular hours of operation but not less than six days or forty hours
a week, shall provide a toll-free telephone service to facilitate
communication between patients in this State and a pharmacist at
the pharmacy who has access to their records. This telephone
number must be printed on a label affixed to the container for the
substance, drug, or device.
(5) An application for a pharmacy permit under the
provisions of this section must be made on a form furnished by the
board, signed by a responsible person who has been designated as
the permit holder, and accompanied by the required fee. The board
may require information from the facility reasonably necessary to
carry out the purposes of this section. Each facility shall apply
individually and obtain a separate permit for each location. The
permit is not transferable and expires annually. A renewal
application must be mailed to the board postmarked no later than
June second or the existing permit lapses on the date of its
expiration, and no renewal permit may be granted except:
(a) upon evidence satisfactory to the board of good and
sufficient grounds for the failure to file the application within the
prescribed period;
(b) upon payment of the renewal fee and a penalty of fifty
dollars.
(6) The board may deny, revoke, suspend, or otherwise take
action against a facility permit issued under the provisions of this
section for:
(a) failure to comply with the requirements of:
(i) this section;
(ii) subsection (C), dealing with prescription drug orders,
drug product selection, labeling, patient records, drug review, drug
dispensing, patient counseling, emergency refills, and
advertisements;
(iii) subchapter 1, Chapter 13, Title 21 of the 1976 Code
(Federal Controlled Substance Act);
(iv) Chapter 2, Title 21 of the Code of Federal
Regulations (Federal Controlled Substance Regulation);
(b) conduct which causes serious bodily or serious
psychological injury to a resident of this State if the board has
referred the matter to the regulatory or licensing agency under
which the pharmacy operates in the state in which it is located and
that agency fails to initiate an investigation within forty-five days of
the referral. The board shall maintain a record of referrals pursuant
to this item and action taken on them.
(7) A facility required to obtain a permit pursuant to this
subsection but which has not been issued a permit, may not
advertise its services in this State, nor may a resident of this State
advertise the services for the facility.
(8) A permit issued pursuant to this section is not evidence
that the pharmacy is doing business within this State.
Section 40-43-90. (A) To obtain a permit, an applicant shall:
(1) submit a written application in the form prescribed by the
Board of Pharmacy at least forty-five days before the opening date
of the facility;
(2) pass an inspection conducted by inspectors of the Board
of Pharmacy; and
(3) pay all appropriate fees.
(B) Applicants for permits to distribute, manufacture, sell,
purchase, or produce drugs or devices within this State shall file
with the Board of Pharmacy a verified application containing such
information as the board requires of the applicant relative to the
qualifications for a permit holder.
(C) Permits issued by the board pursuant to this chapter are not
transferable or assignable.
Section 40-43-91. (A) All permit holders shall report to the
Board of Pharmacy within three working days of the discovery of
the occurrence of:
(1) theft or loss of drugs or devices;
(2) conviction of any employee of any state or federal drug
laws.
(B) All permit holders shall report to the Board of Pharmacy
within ten working days of the discovery of the occurrence of any
of the following:
(1) permanent closing;
(2) change of ownership, management, location, consultant
pharmacists, or pharmacist-in-charge of a pharmacy;
(3) change in employment of pharmacists or pharmacy
technicians within a pharmacy permitted by the board;
(4) disasters, accidents, destruction, or loss of records
required to be maintained by state or federal law.
(C) Upon permanent closing a permittee shall return the permit
to the board within thirty days.
(D) The board may assess a civil penalty of not more than one
hundred dollars upon any individual who fails to comply with the
rules as provided in this section.
(E) Any currently licensed pharmacist or pharmacy technician
who changes his mailing address must notify the board in writing
within ten days listing his name, license or registration number, and
new mailing address.
(F) When a licensed pharmacist in the employ of or in charge of
the pharmacy duties of a permitted facility within this State leaves
the employ of or ceases to have charge of the pharmaceutical duties
of the permitted facility, he shall notify the board in writing within
ten days of the change, giving the name and address of the
permitted facility at which he was last employed. When a licensed
pharmacist or registered pharmacy technician within this State
makes any change in employment from one permitted facility to
another, he shall notify the board of the change within ten days,
listing the name and address of the permitted facility at which he
was last employed and of the facility to which he expects to move.
Section 40-43-100. The examination for licensure required under
Section 40-43-80 must be given by the board at least two times
during each year. The examination must be prepared to measure the
competency of an applicant to engage in the practice of pharmacy.
Section. 40-43-110. (A) For permits not renewed by the
expiration date specified on the permit, the board may charge late
penalties as follows:
(1) ten dollars a day if renewed during the first thirty days
following expiration;
(2) failure to renew by the end of thirty days following
expiration shall result in automatic cancellation of the permit and
application for a new permit is required.
(B) Upon the occurrence of any of the following, an existing
permit is void and a new permit must be applied for:
(1) change of ownership:
(a) any change of ownership in the case of a sole
proprietorship;
(b) a gain or loss of a partner in the case of a partnership;
(c) a change of ownership of fifty percent or more of stock
in the case of a corporation.
2) change of name; or
3) change of location.
A change in location of a permit within the same city requires an
inspection and the payment of a relocation fee.
(C) The board may, upon application and payment of the
applicable renewal fee, issue an inactive status license to a licensed
pharmacist who is not actively engaged in the practice of pharmacy
in this State, pursuant to this chapter. The pharmacist's license
renewal certificate must be prominently marked as an inactive
license, and the holder may not practice pharmacy under any
conditions in this State. If the pharmacist wishes to reactivate the
license, he shall complete the required continuing education for
license renewal, plus an additional fifteen hours which must have
been obtained during the calendar year immediately preceding the
reactivation.
(D) (1) After May first, a license which has not been renewed
is considered a lapsed license. A person who practices pharmacy
with a license that has lapsed is considered practicing without a
license. Reinstatement of a lapsed license may be granted upon
evidence satisfactory to the board of good and sufficient grounds
for the failure to renew the license within the prescribed period and
payment of the renewal fee and a penalty of fifty dollars.
(2) A pharmacist whose license has lapsed for less than three
years may reactivate his license by applying to the board,
submitting proof of completion of 1.5 CEU's for each year the
license has lapsed, and paying the reactivation fee.
(3) A pharmacist whose license has lapsed for three years but
less than five years may reactivate his license by applying to the
board, demonstrating to the board evidence of no less than one
thousand hours of practice under the on-site supervision of a
pharmacist licensed in this State and paying the reactivation fee.
(4) A pharmacist whose license has lapsed for ten years or
more may reactivate his license by applying to the board,
demonstrating to the board evidence of no less than one thousand
hours of practice under the on-site supervision of a pharmacist
licensed in this State, successfully passing an examination
administered or approved by the board, and paying the reactivation
fee.
(5) (a) A pharmacist whose license has lapsed for less than
three years and who has active status outside of South Carolina may
reinstate his license by submitting proof of completion of 1.5
CEU's for each year the license has lapsed, official verification of a
current license, and paying the reactivation fee.
(b) A pharmacist whose license has lapsed for three years
or more and who has active status outside of South Carolina may
reinstate his license by submitting evidence of no less than one
thousand hours of out-of-state employment within the last five
years, official verification of a current license, and paying the
reactivation fee.
(E) (1) Each licensed pharmacist shall apply for renewal of his
license annually no later than April first. A licensed pharmacist
who desires to continue in the practice of pharmacy in this State
shall file with the board an application in such form and containing
data as the board requires for renewal of the license. If the board
finds that the applicant has been licensed, and that the license has
not been revoked or suspended or otherwise disciplined, that the
applicant has paid the renewal fee and has completed all pharmacy
education requirements for continuing education in accordance with
this chapter, the board shall issue a license to the applicant.
(2) If a pharmacist fails to make application to the Board of
Pharmacy for renewal of his license within a period of three years
from the expiration of his license, he must pass the Pharmacy Law
Examination for license renewal; except that a person who has been
licensed under the laws of this State and after the expiration of his
license has continually practiced pharmacy in another state under a
license issued by the authority of such state, may renew his license
upon payment of the designated fee and proof of completion of
thirty hours of continuing education on a form approved by the
board.
(3) Those assistant pharmacists currently licensed have all the
rights and privileges of a licensed pharmacist.
(F) No temporary license may be issued.
Section 40-43-130. (A) Topics and formats of study for
continuing education shall include subject matter designed to
maintain the professional competence of pharmacists licensed to
practice and to improve their professional skills in order to protect
the public health and safety.
(B) Each licensed pharmacist, as a condition of an active status
license renewal, shall complete fifteen hours (1.5 CEU's) of
American Council on Pharmaceutical Education (ACPE) accredited
continuing pharmacy education or continuing medical education
(CME), Category I, or both, each license year. Of the fifteen hours,
a minimum of six hours must be obtained through attendance at
lectures, seminars, or workshops. At least fifty percent of the total
number of hours required must be in drug therapy or patient
management.
(C) All hours completed in any license year in excess of the
requirement may be carried forward for credit in the next license
year, but may not be carried forward for more than one license
year.
(D) Upon licensure in this State by examination or by license
transfer, pharmacists are exempt from continuing education
requirements for the first renewal period.
(E) A copy of the original certificates of completion of the
required continuing education shall be submitted to the board upon
completion.
(F) An exemption may be granted by the board for pharmacists
enrolled in an approved pharmacy postgraduate degree program.
Application must be made to the board and grade reports must be
submitted to the board.
Section 40-43-140. (A)(1) The board may suspend, revoke,
deny, or refuse to renew the permit of a permittee or impose
disciplinary action authorized by this chapter for:
(a) violations of any of the provisions of this chapter or
any regulations promulgated pursuant to this chapter;
(b) retaining as an employee a person who wilfully or
habitually violates any of the state or federal laws applicable to a
permitted facility or its operation.
(2) A person who distributes or delivers drugs or devices to a
person not permitted in accordance with this chapter is subject to a
fine to be imposed by the board not to exceed one thousand dollars
for each offense in addition to such other disciplinary action the
board may take under this chapter. Each violation constitutes a
misdemeanor punishable by a fine not to exceed five thousand
dollars or imprisonment not to exceed one year, or both.
(3) Facilities requiring permits may not operate unless a
permit has been issued by the board.
(4) Except where otherwise allowed by law, it is unlawful for
a manufacturer or a wholesale distributor to distribute or deliver
drugs or devices to any person in this State not permitted under this
chapter.
(a) conviction for a violation of any federal, state, or local
law relating to the practice of pharmacy, drug samples, wholesale or
retail drug or device distribution, or illegal use of or distribution of
controlled substances;
(b) the furnishing of false or fraudulent material in any
appli3cation made in connection with drug or device manufacturing
or distribution;
(c) suspension or revocation by federal, state, or local
government of any permit or license currently or previously held by
the applicant for the manufacture or distribution of any drugs or
devices, including controlled substances;
(d) obtaining remuneration by fraud, misrepresentation, or
deception;
(e) dealing with drugs or devices that they know or should
have known are stolen drugs or devices;
Section 40-43-150. (A) Investigations and hearings must be
conducted in accordance with the provisions of Section 40-1-80.
(B) Restraining orders and cease and desist orders shall be
issued in accordance with the provisions of Section 40-1-100.
(C) Upon determination by the board that one or more of the
grounds for disciplining a licensee or permittee exists, as provided
for in Section 40-1-110, the board may in addition to the actions
provided for in Section 40-1-120 impose a fine not to exceed an
amount set by the board in regulation.
(D) A licensee or permittee who is under investigation for any
of the grounds provided for in Section 40-36-110 for which the
board may take disciplinary action must voluntarily surrender his
license or permit to the board in accordance with Section 40-1-150.
(E) A person aggrieved by an action of the board may seek
review of the decision in accordance with Section 40-1-160.
Section 40-43-160. (A) An individual who, after a hearing,
shall be found by the board to have unlawfully engaged in the
practice of pharmacy is subject to a fine to be imposed by the board
not to exceed an amount set by the board in regulation for each
offense.
(B) Each violation of this chapter or the regulations promulgated
under this chapter pertaining to unlawfully engaging in the practice
of pharmacy shall also constitute a misdemeanor and, upon
conviction, is punishable as provided in Section
40-1-210."
SECTION 2. This act takes effect upon the approval of the
Governor.
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